The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are ...
FDA Device Recall #Z-0633-2014 — Class II — November 21, 2013
Recall Summary
| Recall Number | Z-0633-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 21, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Welch Allyn Protocol, Inc |
| Location | Beaverton, OR |
| Product Type | Devices |
| Quantity | 6003 units total (1715 units in the US and 4288 outside the US) |
Product Description
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
Reason for Recall
Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa.
Lot / Code Information
SERIAL NUMBERS OF DEVICES DISTRIBUTED IN THE US: KA008788, KA009581, KA009685, KA009776, KA009917, KA010079, KA010193, KA010996, KA011141, KA011192, KA011227, KA011228, KA011231, KA011249, KA011303, KA011307, KA011311, KA011314, KA011327, KA011355, KA011356, KA011609, KA011610, KA011611, KA011667, KA011671, KA011672, KA011673, KA011674, KA011675, KA011676, KA011677, KA011678, KA011682, KA011731, KA011758, KA020006, KA020007, KA020008, KA020009, KA020010, KA020011, KA020012, KA020013, KA020014, KA020015, KA020016, KA020018, KA020023, KA020088, KA020091, KA020092, KA020093, KA020116, KA020135, KA020140, KA020149, KA020150, KA020151, KA020192, KA020200, KA020206, KA020207, KA020208, KA020209, KA020210, KA020211, KA020212, KA020213, KA020214, KA020215, KA020262, KA020264, KA020265, KA020266, KA020269, KA020270, KA020273, KA020295, KA020299, KA020304, KA020310, KA020311, KA020313, KA020314, KA020321, KA020381, KA020385, KA020386, KA020387, KA020388, KA020389, KA020390, KA020391, KA020392, KA020393, KA020394, KA020405, KA020406, KA020407, KA020408, KA020409, KA020410, KA020411, KA020412, KA020413, KA020414, KA020417, KA020422, KA020423, KA020424, KA020425, KA020426, KA020427, KA020429, KA020430, KA020432, KA020433, KA020435, KA020436, KA020437, KA020438, KA020439, KA020442, KA020443, KA020444, KA020445, KA020446, KA020447, KA020448, KA020449, KA020450, KA020451, KA020452, KA020453, KA020454, KA020455, KA020456, KA020457, KA020458, KA020459, KA020460, KA020461, KA020462, KA020463, KA020464, KA020465, KA020466, KA020467, KA020468, KA020469, KA020470, KA020471, KA020472, KA020473, KA020474, KA020475, KA020477, KA020478, KA020479, KA020480, KA020481, KA020482, KA020483, KA020526, KA020529, KA020532, KA020533, KA020534, KA020535, KA020536, KA020537, KA020538, KA020540, KA020541, KA020542, KA020543, KA020545, KA020546, KA020547, KA020548, KA020549, KA020550, KA020551, KA020552, KA020553, KA020554, KA020555, KA020556, KA020557, KA020558, KA020559, KA020560, KA020561, KA020562, KA020563, KA020564, KA020575, KA020576, KA020577, KA020578, KA020581, KA020582, KA020595, KA020596, KA020597, KA020606, KA020611, KA020613, KA020617, KA020631, KA020632, KA020633, KA020641, KA020646, KA020649, KA020650, KA020655, KA020659, KA020666, KA020685, KA020691, KA020692, KA020693, KA020726, KA020729, KA020742, KA020743, KA020746, KA020748, KA020853, KA020908, KA020909, KA020916, KA020917, KA021019, KA021028, KA021043, KA021048, KA021061, KA021062, KA021063, KA021064, KA021065, KA021086, KA021126, KA021151, KA021155, KA021158, KA021159, KA021170, KA021181, KA021182, KA021184, KA021188, KA021190, KA021202, KA021221, KA021277, KA021278, KA021279, KA021280, KA021286, KA021294, KA021298, KA021299, KA021311, KA021312, KA021313, KA021318, KA021319, KA021322, KA021323, KA021327, KA021330, KA021349, KA021365, KA021366, KA021367, KA021368, KA021369, KA021370, KA021371, KA021392, KA021393, KA021394, KA021395, KA021396, KA021397, KA021398, KA021399, KA021401, KA021402, KA021403, KA021406, KA021407, KA021408, KA021410, KA021413, KA021415, KA021417, KA021419, KA021426, KA021427, KA021429, KA021462, KA021465, KA021466, KA021469, KA021486, KA021492, KA021495, KA021503, KA021511, KA021516, KA021522, KA021524, KA021529, KA021531, KA021534, KA021545, KA021546, KA021547, KA021549, KA021552, KA021553, KA021556, KA021557, KA021558, KA021559, KA021560, KA021562, KA021563, KA021564, KA021565, KA021566, KA021567, KA021568, KA021569, KA021570, KA021572, KA021576, KA021587, KA021588, KA021589, KA021590, KA021591, KA021592, KA021598, KA021606, KA021609, KA021611, KA021613, KA021614, KA021615, KA021616, KA021623, KA021624, KA021626, KA021630, KA021632, KA021635, KA021670, KA021679, KA021702, KA021704, KA021705, KA021706, KA021707, KA021708, KA021709, KA021711, KA021713, KA021714, KA021715, KA021716, KA021722, KA021723, KA021741, KA021742, KA021745, KA021746, KA021748, KA021749, KA021750, KA021765, KA021766, KA021786, KA021787, KA021788, KA021790, KA021799, KA021803, KA021804, KA021805, KA021806, KA021810, KA021811, KA021821, KA021827, KA021829, KA021866, KA021867, KA021870, KA021884, KA021898, KA021901, KA021902, KA021909, KA021911, KA021912, KA021914, KA021922, KA021925, KA021929, KA021948, KA021949, KA021951, KA021967, KA021968, KA021971, KA021976, KA022012, KA022017, KA022018, KA022020, KA022022, KA022023, KA022024, KA022025, KA022026, KA022027, KA022028, KA022029, KA022030, KA022031, KA022032, KA022036, KA022041, KA022042, KA022043, KA022044, KA022045, KA022049, KA022050, KA022051, KA022052, KA022053, KA022079, KA022081, KA022086, KA022088, KA022089, KA022090, KA022091, KA022092, KA022093, KA022094, KA022095, KA022096, KA022098, KA022099, KA022100, KA022101, KA022102, KA022103, KA022104, KA022105, KA022106, KA022107, KA022108, KA022111, KA022112, KA022113, KA022114, KA022115, KA022125, KA022148, KA022149, KA022150, KA022151, KA022152, KA022155, KA022156, KA022157, KA022158, KA022159, KA022160, KA022161, KA022162, KA022163, KA022164, KA022165, KA022166, KA022167, KA022168, KA022169, KA022172, KA022174, KA022175, KA022176, KA022178, KA022179, KA022180, KA022182, KA022183, KA022184, KA022185, KA022186, KA022187, KA022188, KA022189, KA022190, KA022191, KA022192, KA022193, KA022194, KA022195, KA022196, KA022197, KA022198, KA022199, KA022200, KA022201, KA022202, KA022203, KA022204, KA022205, KA022206, KA022207, KA022208, KA022209, KA022210, KA022211, KA022212, KA022213, KA022214, KA022215, KA022216, KA022217, KA022218, KA022219, KA022220, KA022221, KA022222, KA022223, KA022224, KA022225, KA022232, KA022233, KA022234, KA022235, KA022236, KA022237, KA022238, KA022239, KA022240, KA022241, KA022244, KA022246, KA022277, KA022279, KA022283, KA022286, KA022310, KA022311, KA022312, KA022313, KA022314, KA022315, KA022355, KA022356, KA022358, KA022468, KA022474, KA022481, KA022482, KA022484, KA022485, KA022486, KA022488, KA022489, KA022512, KA022513, KA022514, KA022515, KA022516, KA022517, KA022518, KA022520, KA022522, KA022524, KA022527, KA022528, KA022560, KA022581, KA022591, KA022592, KA022593, KA022594, KA022595, KA022596, KA022610, KA022612, KA022614, KA022619, KA022621, KA022622, KA022623, KA022624, KA022625, KA022626, KA022627, KA022628, KA022629, KA022630, KA022631, KA022632, KA022633, KA022634, KA022635, KA022636, KA022637, KA022638, KA022639, KA022640, KA022641, KA022642, KA022643, KA022644, KA022645, KA022646, KA022647, KA022648, KA022649, KA022650, KA022651, KA022652, KA022653, KA022654, KA022655, KA022656, KA022657, KA022658, KA022659, KA022660, KA022661, KA022662, KA022663, KA022664, KA022665, KA022666, KA022667, KA022668, KA022671, KA022673, KA022674, KA022676, KA022677, KA022678, KA022679, KA022680, KA022681, KA022682, KA022683, KA022684, KA022685, KA022686, KA022687, KA022688, KA022689, KA022690, KA022691, KA022692, KA022693, KA022694, KA022695, KA022696, KA022697, KA022698, KA022699, KA022700, KA022701, KA022702, KA022703, KA022704, KA022705, KA022706, KA022707, KA022708, KA022709, KA022710, KA022711, KA022712, KA022713, KA022714, KA022715, KA022716, KA022717, KA022718, KA022719, KA022720, KA022721, KA022722, KA022723, KA022724, KA022725, KA022726, KA022727, KA022728, KA022729, KA022730, KA022731, KA022732, KA022733, KA022734, KA022736, KA022737, KA022741, KA022743, KA022744, KA022745, KA022746, KA022747, KA022748, KA022752, KA022753, KA022754, KA022755, KA022756, KA022757, KA022758, KA022759, KA022761, KA022762, KA022763, KA022764, KA022765, KA022766, KA022767, KA022768, KA022769, KA022770, KA022771, KA022772, KA022773, KA022774, KA022775, KA022776, KA022777, KA022778, KA022779, KA022780, KA022781, KA022782, KA022783, KA022784, KA022786, KA022788, KA022789, KA022790, KA022793, KA022795, KA022802, KA022803, KA022805, KA022806, KA022808, KA022809, KA022810, KA022811, KA022812, KA022813, KA022814, KA022815, KA022816, KA022818, KA022819, KA022820, KA022821, KA022822, KA022823, KA022824, KA022825, KA022826, KA022827, KA022828, KA022829, KA022830, KA022831, KA022832, KA022833, KA022834, KA022835, KA022836, KA022837, KA022838, KA022839, KA022840, KA022841, KA022842, KA022844, KA022845, KA022846, KA022847, KA022848, KA022849, KA022850, KA022851, KA022852, KA022853, KA022854, KA022855, KA022856, KA022857, KA022858, KA022859, KA022860, KA022861, KA022862, KA022863, KA022864, KA022865, KA022866, KA022867, KA022868, KA022869, KA022870, KA022871, KA022872, KA022873, KA022874, KA022875, KA022876, KA022877, KA022878, KA022879, KA022880, KA022881, KA022882, KA022883, KA022884, KA022885, KA022886, KA022887, KA022888, KA022889, KA022890, KA022891, KA022892, KA022893, KA022894, KA022895, KA022903, KA022904, KA022905, KA022906, KA022908, KA022909, KA022911, KA022912, KA022913, KA022914, KA022915, KA022917, KA022920, KA022943, KA022958, KA022973, KA022974, KA022975, KA022976, KA022984, KA022985, KA022986, KA023057, KA023058, KA023061, KA023063, KA023064, KA023065, KA023067, KA023068, KA023069, KA023070, KA023071, KA023072, KA023073, KA023075, KA023078, KA023080, KA023081, KA023082, KA023083, KA023084, KA023085, KA023086, KA023087, KA023094, KA023095, KA023096, KA023097, KA023098, KA023104, KA023105, KA023106, KA023107, KA023108, KA023109, KA023110, KA023111, KA023112, KA023113, KA023114, KA023115, KA023116, KA023117, KA023118, KA023119, KA023120, KA023121, KA023122, KA023123, KA023124, KA023125, KA023126, KA023127, KA023128, KA023129, KA023130, KA023131, KA023132, KA023133, KA023134, KA023135, KA023136, KA023137, KA023139, KA023140, KA023141, KA023142, KA023172, KA023199, KA023200, KA023201, KA023202, KA023203, KA023204, KA023205, KA023226, KA023249, KA023251, KA023271, KA023273, KA023282, KA023283, KA023284, KA023285, KA023286, KA023287, KA023288, KA023289, KA023290, KA023291, KA023292, KA023293, KA023294, KA023295, KA023296, KA023297, KA023298, KA023299, KA023300, KA023301, KA023302, KA023327, KA023328, KA023329, KA023330, KA023331, KA023332, KA023333, KA023334, KA023335, KA023336, KA023337, KA023338, KA023339, KA023340, KA023341, KA023342, KA023343, KA023344, KA023345, KA023346, KA023348, KA023349, KA023350, KA023351, KA023352, KA023353, KA023354, KA023355, KA023356, KA023358, KA023359, KA023360, KA023361, KA023362, KA023363, KA023364, KA023365, KA023367, KA023368, KA023374, KA023376, KA023379, KA023380, KA023381, KA023383, KA023385, KA023387, KA023388, KA023389, KA023390, KA023391, KA023392, KA023393, KA023395, KA023396, KA023397, KA023398, KA023399, KA023416, KA023418, KA023420, KA023421, KA023424, KA023429, KA023430, KA023431, KA023432, KA023433, KA023443, KA023444, KA023445, KA023450, KA023475, KA023476, KA023477, KA023478, KA023479, KA023480, KA023481, KA023507, KA023508, KA023509, KA023510, KA023511, KA023512, KA023513, KA023514, KA023515, KA023516, KA023517, KA023518, KA023583, KA023584, KA023585, KA023586, KA023587, KA023588, KA023589, KA023590, KA023591, KA023592, KA023593, KA023594, KA023595, KA023631, KA023632, KA023640, KA023642, KA023651, KA023654, KA023655, KA023657, KA023658, KA023659, KA023665, KA023673, KA023674, KA023675, KA023683, KA023687, KA023689, KA023694, KA023696, KA023699, KA023700, KA023702, KA023703, KA023705, KA023706, KA023707, KA023708, KA023709, KA023710, KA023712, KA023713, KA023714, KA023716, KA023717, KA023718, KA023719, KA023720, KA023721, KA023727, KA023730, KA023731, KA023732, KA023733, KA023734, KA023735, KA023736, KA023737, KA023738, KA023739, KA023740, KA023741, KA023742, KA023744, KA023745, KA023746, KA023747, KA023748, KA023749, KA023750, KA023751, KA023752, KA023753, KA023754, KA023755, KA023756, KA023757, KA023758, KA023759, KA023760, KA023761, KA023762, KA023763, KA023764, KA023765, KA023766, KA023767, KA023771, KA023772, KA023773, KA023774, KA023775, KA023776, KA023777, KA023778, KA023779, KA023780, KA023781, KA023782, KA023785, KA023786, KA023788, KA023789, KA023792, KA023793, KA023794, KA023795, KA023796, KA023797, KA023798, KA023800, KA023801, KA023802, KA023803, KA023805, KA023806, KA023807, KA023809, KA023824, KA023825, KA023827, KA023830, KA023836, KA023839, KA023841, KA023844, KA023845, KA023846, KA023847, KA023848, KA023849, KA023851, KA023855, KA023858, KA023859, KA023863, KA023865, KA023866, KA023867, KA023868, KA023870, KA023882, KA023884, KA023885, KA023886, KA023887, KA023888, KA023889, KA023890, KA023923, KA023955, KA023957, KA023976, KA023986, KA023992, KA023994, KA023997, KA024003, KA024014, KA024017, KA024018, KA024022, KA024023, KA024025, KA024051, KA024054, KA024071, KA024093, KA024107, KA024145, KA024171, KA024193, KA024200, KA024201, KA024202, KA024203, KA024204, KA024205, KA024206, KA024207, KA024208, KA024209, KA024210, KA024211, KA024212, KA024225, KA024227, KA024228, KA024229, KA024230, KA024231, KA024232, KA024233, KA024235, KA024236, KA024237, KA024239, KA024240, KA024241, KA024246, KA024247, KA024248, KA024249, KA024250, KA024251, KA024252, KA024253, KA024255, KA024259, KA024260, KA024263, KA024267, KA024269, KA024276, KA024282, KA024283, KA024284, KA024285, KA024286, KA024287, KA024298, KA024300, KA024301, KA024302, KA024303, KA024304, KA024305, KA024306, KA024307, KA024308, KA024310, KA024311, KA024312, KA024313, KA024314, KA024315, KA024316, KA024318, KA024319, KA024321, KA024322, KA024323, KA024324, KA024325, KA024327, KA024331, KA024332, KA024333, KA024334, KA024335, KA024339, KA024343, KA024344, KA024345, KA024351, KA024353, KA024355, KA024369, KA024370, KA024374, KA024375, KA024377, KA024378, KA024379, KA024380, KA024381, KA024382, KA024383, KA024384, KA024385, KA024386, KA024387, KA024388, KA024389, KA024390, KA024391, KA024392, KA024393, KA024394, KA024395, KA024397, KA024399, KA024400, KA024406, KA024407, KA024421, KA024433, KA024436, KA024439, KA024440, KA024441, KA024442, KA024448, KA024449, KA024452, KA024484, KA024485, KA024490, KA024491, KA024492, KA024498, KA024499, KA024500, KA024503, KA024505, KA024506, KA024509, KA024510, KA024512, KA024514, KA024516, KA024517, KA024518, KA024519, KA024521, KA024522, KA024523, KA024524, KA024594, KA024617, KA024618, KA024619, KA024620, KA024621, KA024622, KA024623, KA024624, KA024625, KA024626, KA024627, KA024628, KA024629, KA024662, KA024666, KA024668, KA024798, KA024801, KA024804, KA024807, KA024809, KA024811, KA024813, KA024814, KA024817, KA024822, KA024870, KA024871, KA024873, KA024900, KA024902, KA024908, KA024915, KA024919, KA024921, KA024922, KA024943, KA024944, KA024945, KA024946, KA024947, KA024948, KA024949, KA024950, KA024951, KA024992, KA024997, KA024998, KA024999, KA025001, KA025003, KA025004, KA025010, KA025011, KA025012, KA025013, KA025016, KA025031, KA025035, KA025041, KA025043, KA025053, KA025062, KA025064, KA025089, KA025090, KA025092, KA025093, KA025095, KA025096, KA025126, KA025144, KA025145, KA025159, KA025160, KA025168, KA025177, KA025180, KA025181, KA025182, KA025183, KA025184, KA025185, KA025186, KA025191, KA025203, KA025204, KA025205, KA025226, KA025229, KA025230, KA025231, KA025232, KA025233, KA025235, KA025236, KA025238, KA025239, KA025240, KA025241, KA025262, KA025263, KA025264, KA025265, KA025266, KA025267, KA025268, KA025269, KA025272, KA025275, KA025280, KA025282, KA025296, KA025302, KA025304, KA025305, KA025306, KA025307, KA025308, KA025309, KA025310, KA025311, KA025312, KA025313, KA025314, KA025315, KA025316, KA025317, KA025318, KA025319, KA025320, KA025321, KA025322, KA025323, KA025325, KA025326, KA025327, KA025330, KA025355, KA025428, KA025433, KA025434, KA025435, KA025436, KA025437, KA025448, KA025510, KA025524, KA025535, KA025578, KA025579, KA025580, KA025581, KA025614, KA025615, KA025616, KA025617, KA025629, KA025733, KA025734, KA025735, KA025736, KA025737, KA025740, KA025875, KA025876, KA025877, KA025879, KA025891, KA025892, KA025898, KA025902, KA025903, KA025908, KA025909, KA025910, KA025911, KA025912, KA025938, KA025939, KA026024, KA026028, KA026029, KA026041, KA026042, KA026045, KA026046, KA026048, KA026049, KA026050, KA026052, KA026053, KA026054, KA026056, KA026057, KA026058, KA026059, KA026062, KA026063, KA026105, KA026107, KA026108, KA026110, KA026111, KA026140, KA026141, KA026142, KA026143, KA026151, KA026152, KA026154, KA026157, KA026178, KA026179, KA026180, KA026181, KA026182, KA026184, KA026263, KA026264, KA026265, KA026278, KA026287, KA026288, KA026302, KA026370, KA026371, KA026372, KA026373, KA026375, KA026376, KA026377, KA026378, KA026379, KA026406, KA026407, KA026408, KA026409, KA026410, KA026412, KA026416, KA026457, KA026499, KA026502, KA026503, KA026504, KA026505, KA026506, KA026507, KA026508, KA026509, KA026573, KA026574, KA026575, KA026576, KA026638, KA026639, KA026751, KA026752, KA026753, KA026763, KA026766, KA026771, KA026774, KA026797, KA026815, KA026816, KA026817, KA026818, KA026819, KA026820, KA026821, KA026822, KA026823, KA026824, KA026825, KA026826, KA026838, KA026849, KA026854, KA026856, KA026857, KA026869, KA026872, KA026933, KA026938, KA026939, KA026941, KA026942, KA026944, KA026945, KA026946, KA026948, KA026950, KA026951, KA026952, KA026953, KA026954, KA026955, KA026956, KA026957, KA026958, KA026959, KA026960, KA026961, KA026962, KA026963, KA026964, KA026985, KA026987, KA026992, KA027029, KA027031, KA027032, KA027033, KA027045, KA027130, KA027134, KA027135, KA027136, KA027137, KA027138, KA027147, KA027148, KA027157, KA21398, KA21399, and KA21407. SERIAL NUMBERS OF DEVICES DISTRIBUTED OUTSIDE THE US: KA002129, KA002130, KA008395, KA008397, KA008401, KA008600, KA008715, KA008794, KA009204, KA009205, KA009208, KA009212, KA009260, KA009268, KA009350, KA009393, KA009394, KA009395, KA009396, KA009397, KA009399, KA009400, KA009402, KA009404, KA009406, KA009407, KA009408, KA009429, KA009438, KA009446, KA009449, KA009451, KA009452, KA009457, KA009458, KA009470, KA009504, KA009572, KA009575, KA009578, KA009579, KA009587, KA009611, KA009665, KA009666, KA009667, KA009668, KA009669, KA009671, KA009672, KA009675, KA009677, KA009690, KA009693, KA009699, KA009707, KA009708, KA009755, KA009796, KA009822, KA009826, KA009827, KA009829, KA009896, KA009897, KA009913, KA009946, KA010203, KA010362, KA010366, KA010370, KA010448, KA010496, KA010548, KA010596, KA010753, KA010787, KA010788, KA010795, KA010835, KA010836, KA010922, KA010923, KA011029, KA011071, KA011075, KA011095, KA011120, KA011150, KA011161, KA011186, KA011189, KA011209, KA011210, KA011211, KA011212, KA011215, KA011218, KA011229, KA011232, KA011263, KA011276, KA011283, KA011394, KA011396, KA011397, KA011399, KA011401, KA011402, KA011403, KA011404, KA011405, KA011409, KA011410, KA011411, KA011412, KA011413, KA011414, KA011416, KA011417, KA011418, KA011419, KA011420, KA011422, KA011423, KA011424, KA011425, KA011426, KA011427, KA011428, KA011430, KA011431, KA011432, KA011433, KA011434, KA011435, KA011436, KA011437, KA011438, KA011439, KA011440, KA011448, KA011449, KA011452, KA011463, KA011467, KA011468, KA011469, KA011470, KA011471, KA011472, KA011473, KA011474, KA011475, KA011476, KA011478, KA011479, KA011480, KA011481, KA011482, KA011483, KA011484, KA011485, KA011488, KA011489, KA011490, KA011491, KA011492, KA011493, KA011494, KA011495, KA011496, KA011497, KA011498, KA011500, KA011501, KA011502, KA011503, KA011504, KA011506, KA011507, KA011508, KA011514, KA011571, KA011573, KA011575, KA011576, KA011580, KA011581, KA011582, KA011583, KA011585, KA011586, KA011587, KA011588, KA011589, KA011596, KA011625, KA011640, KA011641, KA011642, KA011643, KA011654, KA011655, KA011657, KA011658, KA011659, KA011660, KA011661, KA011662, KA011663, KA011664, KA011665, KA011666, KA011668, KA011669, KA011670, KA011680, KA011683, KA011703, KA011704, KA011730, KA011735, KA011737, KA011738, KA011741, KA011742, KA011743, KA011745, KA011746, KA011754, KA011755, KA011756, KA011757, KA011760, KA011761, KA011763, KA011765, KA011766, KA011767, KA011768, KA011771, KA011793, KA020017, KA020019, KA020020, KA020021, KA020022, KA020024, KA020025, KA020086, KA020087, KA020089, KA020090, KA020094, KA020095, KA020114, KA020115, KA020117, KA020118, KA020119, KA020120, KA020121, KA020122, KA020123, KA020124, KA020125, KA020126, KA020127, KA020128, KA020129, KA020130, KA020131, KA020132, KA020133, KA020134, KA020136, KA020137, KA020138, KA020139, KA020141, KA020142, KA020143, KA020144, KA020145, KA020146, KA020147, KA020148, KA020152, KA020153, KA020189, KA020190, KA020191, KA020193, KA020196, KA020197, KA020198, KA020199, KA020201, KA020202, KA020203, KA020204, KA020205, KA020231, KA020256, KA020257, KA020258, KA020259, KA020260, KA020261, KA020263, KA020267, KA020268, KA020271, KA020272, KA020274, KA020275, KA020286, KA020287, KA020288, KA020289, KA020290, KA020291, KA020292, KA020293, KA020294, KA020296, KA020297, KA020298, KA020300, KA020301, KA020302, KA020303, KA020305, KA020306, KA020307, KA020308, KA020309, KA020312, KA020315, KA020316, KA020317, KA020318, KA020319, KA020320, KA020322, KA020323, KA020324, KA020325, KA020326, KA020349, KA020350, KA020351, KA020352, KA020353, KA020354, KA020355, KA020356, KA020357, KA020358, KA020373, KA020374, KA020375, KA020376, KA020377, KA020378, KA020379, KA020380, KA020382, KA020383, KA020384, KA020400, KA020401, KA020402, KA020403, KA020404, KA020415, KA020416, KA020418, KA020419, KA020420, KA020421, KA020428, KA020431, KA020434, KA020440, KA020441, KA020476, KA020484, KA020525, KA020527, KA020528, KA020530, KA020531, KA020539, KA020544, KA020579, KA020580, KA020583, KA020584, KA020585, KA020586, KA020587, KA020588, KA020589, KA020590, KA020591, KA020592, KA020593, KA020594, KA020598, KA020599, KA020600, KA020601, KA020602, KA020603, KA020604, KA020605, KA020607, KA020608, KA020609, KA020610, KA020612, KA020614, KA020615, KA020616, KA020618, KA020619, KA020630, KA020634, KA020635, KA020636, KA020637, KA020638, KA020639, KA020640, KA020642, KA020643, KA020644, KA020645, KA020647, KA020648, KA020651, KA020652, KA020653, KA020654, KA020656, KA020657, KA020658, KA020660, KA020661, KA020662, KA020663, KA020664, KA020665, KA020667, KA020668, KA020669, KA020680, KA020681, KA020682, KA020683, KA020684, KA020686, KA020687, KA020688, KA020689, KA020690, KA020694, KA020700, KA020701, KA020702, KA020703, KA020704, KA020705, KA020706, KA020707, KA020708, KA020709, KA020710, KA020711, KA020712, KA020713, KA020714, KA020715, KA020716, KA020717, KA020718, KA020719, KA020720, KA020721, KA020722, KA020723, KA020724, KA020725, KA020727, KA020728, KA020730, KA020731, KA020732, KA020733, KA020734, KA020735, KA020736, KA020737, KA020738, KA020739, KA020740, KA020741, KA020744, KA020745, KA020747, KA020749, KA020750, KA020751, KA020752, KA020753, KA020754, KA020755, KA020756, KA020757, KA020758, KA020759, KA020781, KA020782, KA020783, KA020784, KA020785, KA020786, KA020787, KA020788, KA020789, KA020790, KA020791, KA020792, KA020793, KA020794, KA020795, KA020796, KA020797, KA020798, KA020799, KA020800, KA020801, KA020802, KA020803, KA020804, KA020805, KA020806, KA020807, KA020808, KA020809, KA020810, KA020811, KA020812, KA020813, KA020814, KA020815, KA020816, KA020817, KA020818, KA020819, KA020820, KA020821, KA020822, KA020823, KA020824, KA020825, KA020826, KA020827, KA020828, KA020829, KA020830, KA020831, KA020832, KA020833, KA020834, KA020835, KA020836, KA020837, KA020838, KA020839, KA020840, KA020841, KA020842, KA020843, KA020844, KA020845, KA020846, KA020847, KA020848, KA020849, KA020850, KA020851, KA020852, KA020854, KA020855, KA020856, KA020857, KA020858, KA020859, KA020860, KA020861, KA020862, KA020863, KA020864, KA020865, KA020866, KA020867, KA020868, KA020869, KA020870, KA020871, KA020872, KA020873, KA020874, KA020875, KA020876, KA020877, KA020878, KA020879, KA020880, KA020881, KA020882, KA020883, KA020884, KA020885, KA020886, KA020887, KA020888, KA020889, KA020890, KA020891, KA020892, KA020893, KA020894, KA020895, KA020896, KA020897, KA020898, KA020899, KA020900, KA020901, KA020902, KA020903, KA020904, KA020905, KA020906, KA020907, KA020910, KA020911, KA020912, KA020913, KA020914, KA020915, KA020918, KA020919, KA020920, KA020921, KA020922, KA020923, KA020924, KA020925, KA020926, KA020927, KA020928, KA020929, KA020930, KA020931, KA020932, KA020933, KA020934, KA020935, KA020936, KA020937, KA020938, KA020939, KA020940, KA020941, KA020942, KA020943, KA020944, KA020945, KA020946, KA020947, KA020948, KA020949, KA020950, KA020951, KA020952, KA020953, KA020954, KA020955, KA020956, KA020957, KA020958, KA020959, KA020960, KA020961, KA020962, KA020963, KA020964, KA020965, KA020966, KA020967, KA020968, KA020969, KA020970, KA020971, KA020972, KA020973, KA020974, KA020975, KA020976, KA020977, KA020978, KA020979, KA020980, KA020981, KA020982, KA020983, KA020984, KA020985, KA020986, KA020987, KA020988, KA020989, KA020990, KA020991, KA020992, KA020993, KA020994, KA020995, KA020996, KA020997, KA020998, KA020999, KA021000, KA021001, KA021002, KA021003, KA021004, KA021005, KA021006, KA021007, KA021008, KA021009, KA021010, KA021011, KA021012, KA021013, KA021014, KA021015, KA021016, KA021017, KA021018, KA021020, KA021021, KA021022, KA021023, KA021024, KA021025, KA021026, KA021027, KA021029, KA021030, KA021031, KA021032, KA021033, KA021034, KA021035, KA021036, KA021037, KA021038, KA021039, KA021040, KA021041, KA021042, KA021044, KA021045, KA021046, KA021047, KA021049, KA021050, KA021051, KA021052, KA021053, KA021054, KA021055, KA021056, KA021057, KA021058, KA021059, KA021060, KA021087, KA021088, KA021089, KA021090, KA021091, KA021092, KA021093, KA021094, KA021095, KA021096, KA021097, KA021098, KA021099, KA021100, KA021101, KA021102, KA021103, KA021104, KA021105, KA021106, KA021107, KA021108, KA021109, KA021110, KA021111, KA021112, KA021113, KA021114, KA021115, KA021116, KA021117, KA021118, KA021119, KA021120, KA021121, KA021122, KA021123, KA021124, KA021125, KA021127, KA021128, KA021129, KA021130, KA021131, KA021132, KA021133, KA021134, KA021135, KA021136, KA021137, KA021138, KA021139, KA021140, KA021141, KA021142, KA021143, KA021144, KA021145, KA021146, KA021147, KA021148, KA021149, KA021150, KA021152, KA021153, KA021154, KA021156, KA021157, KA021160, KA021161, KA021162, KA021163, KA021164, KA021165, KA021166, KA021167, KA021168, KA021169, KA021171, KA021172, KA021173, KA021174, KA021175, KA021176, KA021177, KA021178, KA021179, KA021180, KA021183, KA021185, KA021186, KA021187, KA021189, KA021191, KA021192, KA021193, KA021194, KA021195, KA021196, KA021197, KA021198, KA021199, KA021200, KA021201, KA021203, KA021204, KA021205, KA021206, KA021207, KA021208, KA021209, KA021210, KA021211, KA021212, KA021213, KA021214, KA021215, KA021216, KA021217, KA021218, KA021219, KA021220, KA021222, KA021223, KA021224, KA021225, KA021226, KA021227, KA021228, KA021229, KA021230, KA021231, KA021232, KA021233, KA021234, KA021235, KA021236, KA021237, KA021238, KA021239, KA021240, KA021241, KA021242, KA021243, KA021244, KA021245, KA021246, KA021247, KA021248, KA021249, KA021250, KA021251, KA021252, KA021253, KA021254, KA021255, KA021256, KA021257, KA021258, KA021259, KA021260, KA021261, KA021262, KA021263, KA021264, KA021265, KA021266, KA021281, KA021282, KA021283, KA021284, KA021285, KA021287, KA021288, KA021289, KA021290, KA021291, KA021292, KA021293, KA021295, KA021296, KA021297, KA021300, KA021301, KA021302, KA021303, KA021304, KA021305, KA021306, KA021307, KA021308, KA021309, KA021310, KA021314, KA021315, KA021316, KA021317, KA021320, KA021321, KA021324, KA021325, KA021326, KA021328, KA021329, KA021331, KA021332, KA021333, KA021334, KA021335, KA021336, KA021337, KA021338, KA021339, KA021340, KA021341, KA021342, KA021343, KA021344, KA021345, KA021346, KA021347, KA021348, KA021350, KA021351, KA021352, KA021353, KA021354, KA021355, KA021356, KA021357, KA021358, KA021359, KA021360, KA021361, KA021362, KA021363, KA021364, KA021400, KA021404, KA021405, KA021409, KA021411, KA021412, KA021414, KA021416, KA021418, KA021420, KA021421, KA021422, KA021423, KA021424, KA021425, KA021428, KA021430, KA021431, KA021432, KA021433, KA021434, KA021435, KA021436, KA021457, KA021458, KA021459, KA021460, KA021461, KA021463, KA021464, KA021467, KA021468, KA021470, KA021471, KA021472, KA021473, KA021474, KA021475, KA021476, KA021477, KA021478, KA021479, KA021480, KA021481, KA021482, KA021483, KA021484, KA021485, KA021487, KA021488, KA021489, KA021490, KA021491, KA021493, KA021494, KA021496, KA021497, KA021498, KA021499, KA021500, KA021501, KA021502, KA021504, KA021505, KA021506, KA021507, KA021508, KA021509, KA021510, KA021512, KA021513, KA021514, KA021515, KA021517, KA021518, KA021519, KA021520, KA021521, KA021523, KA021525, KA021526, KA021527, KA021528, KA021530, KA021532, KA021533, KA021535, KA021536, KA021537, KA021538, KA021539, KA021540, KA021542, KA021543, KA021544, KA021548, KA021550, KA021551, KA021554, KA021555, KA021561, KA021571, KA021573, KA021574, KA021575, KA021577, KA021578, KA021579, KA021580, KA021581, KA021582, KA021583, KA021586, KA021593, KA021594, KA021595, KA021596, KA021599, KA021600, KA021601, KA021602, KA021603, KA021605, KA021608, KA021610, KA021612, KA021617, KA021618, KA021619, KA021620, KA021621, KA021622, KA021625, KA021627, KA021628, KA021629, KA021631, KA021633, KA021634, KA021636, KA021637, KA021638, KA021639, KA021640, KA021641, KA021659, KA021660, KA021661, KA021662, KA021663, KA021664, KA021665, KA021666, KA021667, KA021668, KA021669, KA021671, KA021672, KA021673, KA021674, KA021675, KA021676, KA021677, KA021678, KA021680, KA021681, KA021682, KA021683, KA021684, KA021685, KA021686, KA021687, KA021688, KA021689, KA021690, KA021691, KA021692, KA021693, KA021694, KA021695, KA021696, KA021697, KA021698, KA021699, KA021700, KA021701, KA021703, KA021710, KA021712, KA021717, KA021718, KA021719, KA021720, KA021721, KA021724, KA021725, KA021726, KA021727, KA021728, KA021729, KA021730, KA021731, KA021732, KA021733, KA021736, KA021737, KA021738, KA021739, KA021740, KA021743, KA021744, KA021747, KA021751, KA021752, KA021763, KA021764, KA021767, KA021768, KA021769, KA021770, KA021771, KA021772, KA021773, KA021774, KA021775, KA021776, KA021777, KA021778, KA021779, KA021780, KA021781, KA021782, KA021783, KA021784, KA021785, KA021789, KA021791, KA021792, KA021793, KA021794, KA021795, KA021796, KA021797, KA021798, KA021800, KA021801, KA021802, KA021807, KA021808, KA021809, KA021812, KA021813, KA021814, KA021815, KA021816, KA021817, KA021818, KA021819, KA021820, KA021822, KA021823, KA021824, KA021825, KA021826, KA021828, KA021830, KA021868, KA021869, KA021871, KA021872, KA021873, KA021874, KA021875, KA021876, KA021877, KA021878, KA021879, KA021880, KA021881, KA021882, KA021885, KA021886, KA021887, KA021888, KA021889, KA021890, KA021894, KA021895, KA021896, KA021897, KA021899, KA021900, KA021903, KA021904, KA021905, KA021906, KA021907, KA021908, KA021910, KA021913, KA021915, KA021916, KA021917, KA021918, KA021919, KA021920, KA021921, KA021923, KA021924, KA021926, KA021927, KA021928, KA021930, KA021950, KA021952, KA021961, KA021962, KA021963, KA021964, KA021965, KA021966, KA021969, KA021970, KA021972, KA021973, KA021974, KA021975, KA021977, KA022010, KA022011, KA022013, KA022014, KA022015, KA022016, KA022019, KA022021, KA022033, KA022034, KA022035, KA022037, KA022038, KA022039, KA022040, KA022046, KA022047, KA022048, KA022054, KA022055, KA022056, KA022057, KA022058, KA022059, KA022060, KA022061, KA022062, KA022063, KA022064, KA022065, KA022066, KA022067, KA022068, KA022069, KA022070, KA022071, KA022072, KA022073, KA022074, KA022075, KA022076, KA022077, KA022078, KA022080, KA022082, KA022083, KA022084, KA022085, KA022087, KA022097, KA022109, KA022110, KA022116, KA022117, KA022118, KA022119, KA022120, KA022121, KA022122, KA022123, KA022124, KA022126, KA022127, KA022128, KA022129, KA022130, KA022131, KA022132, KA022133, KA022134, KA022135, KA022136, KA022137, KA022138, KA022139, KA022140, KA022141, KA022142, KA022143, KA022144, KA022145, KA022146, KA022147, KA022153, KA022154, KA022170, KA022171, KA022173, KA022177, KA022181, KA022226, KA022228, KA022229, KA022230, KA022231, KA022242, KA022243, KA022245, KA022247, KA022248, KA022249, KA022250, KA022251, KA022252, KA022253, KA022254, KA022255, KA022256, KA022257, KA022258, KA022259, KA022260, KA022261, KA022262, KA022263, KA022264, KA022265, KA022266, KA022267, KA022268, KA022269, KA022270, KA022271, KA022272, KA022273, KA022274, KA022275, KA022276, KA022278, KA022280, KA022281, KA022282, KA022284, KA022285, KA022287, KA022288, KA022289, KA022290, KA022291, KA022292, KA022293, KA022294, KA022295, KA022296, KA022297, KA022298, KA022299, KA022300, KA022301, KA022302, KA022303, KA022304, KA022305, KA022306, KA022307, KA022308, KA022309, KA022316, KA022317, KA022318, KA022319, KA022320, KA022321, KA022322, KA022323, KA022324, KA022325, KA022326, KA022327, KA022328, KA022329, KA022330, KA022331, KA022332, KA0223
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.