Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Us...
FDA Device Recall #Z-1232-2014 — Class II — February 6, 2014
Recall Summary
| Recall Number | Z-1232-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 6, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems North America Inc. |
| Location | Bothell, WA |
| Product Type | Devices |
| Quantity | 5075 units total (2724 units in the US and 2351 units outside the US) |
Product Description
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
Reason for Recall
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
Distribution Pattern
Worldwide Distribution - USA Nationwide
Lot / Code Information
SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA: A13G-00001, A13G-00002, A13G-00003, A13G-00004, A13G-00005, A13G-00006, A13G-00007, A13G-00008, A13G-00009, A13G-00010, A13G-00011, A13G-00012, A13G-00013, A13G-00014, A13G-00015, A13G-00016, A13G-00017, A13G-00018, A13G-00019, A13G-00020, A13G-00021, A13G-00022, A13G-00023, A13G-00024, A13G-00025, A13G-00026, A13G-00027, A13G-00028, A13G-00029, A13G-00030, A13G-00031, A13G-00032, A13G-00033, A13G-00034, A13G-00035, A13G-00036, A13G-00037, A13G-00038, A13G-00039, A13G-00040, A13G-00041, A13G-00042, A13G-00043, A13G-00044, A13G-00045, A13G-00046, A13G-00047, A13G-00048, A13G-00049, A13G-00050, A13G-00051, A13G-00052, A13G-00053, A13G-00054, A13G-00055, A13G-00056, A13G-00057, A13G-00058, A13G-00059, A13G-00060, A13G-00061, A13G-00062, A13G-00063, A13G-00064, A13G-00065, A13G-00067, A13G-00068, A13G-00069, A13G-00070, A13G-00071, A13G-00072, A13G-00073, A13G-00074, A13G-00075, A13G-00076, A13G-00077, A13G-00078, A13G-00079, A13G-00080, A13G-00081, A13G-00082, A13G-00083, A13G-00084, A13G-00085, A13G-00086, A13G-00087, A13G-00088, A13G-00089, A13G-00090, A13G-00091, A13G-00092, A13G-00093, A13G-00095, A13G-00096, A13G-00097, A13G-00098, A13G-00099, A13G-00100, A13G-00101, A13G-00102, A13G-00103, A13G-00104, A13G-00105, A13G-00106, A13G-00107, A13G-00108, A13G-00109, A13G-00110, A13G-00111, A13G-00112, A13G-00114, A13G-00115, A13G-00116, A13G-00117, A13G-00118, A13G-00119, A13G-00120, A13G-00122, A13G-00123, A13G-00124, A13G-00125, A13G-00126, A13G-00127, A13G-00128, A13G-00129, A13G-00130, A13G-00131, A13G-00132, A13G-00133, A13G-00134, A13G-00135, A13G-00136, A13G-00137, A13G-00138, A13G-00139, A13G-00140, A13G-00141, A13G-00142, A13G-00143, A13G-00144, A13G-00145, A13G-00146, A13G-00147, A13G-00148, A13G-00149, A13G-00150, A13G-00151, A13G-00152, A13G-00153, A13G-00154, A13G-00155, A13G-00156, A13G-00157, A13G-00158, A13G-00159, A13G-00160, A13G-00161, A13G-00162, A13G-00163, A13G-00164, A13G-00165, A13G-00166, 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A13G-00851, A13G-00852, A13G-00853, A13G-00854, A13G-00855, A13G-00856, A13G-00859, A13G-00860, A13G-00861, A13G-00862, A13G-00863, A13G-00865, A13G-00870, A13G-00874, A13G-00875, A13G-00877, A13G-00878, A13G-00880, A13G-00881, A13G-00883, A13G-00884, A13G-00885, A13G-00886, A13G-00887, A13G-00889, A13G-00891, A13G-00892, A13G-00894, A13G-00896, A13G-00897, A13G-00898, A13G-00899, A13G-00900, A13G-00902, A13G-00903, A13G-00904, A13G-00905, A13G-00906, A13G-00907, A13G-00908, A13G-00909, A13G-00910, A13G-00911, A13G-00912, A13G-00913, A13G-00914, A13G-00915, A13G-00916, A13G-00917, A13G-00918, A13G-00919, A13G-00920, A13G-00921, A13G-00922, A13G-00923, A13G-00924, A13G-00925, A13G-00927, A13G-00928, A13G-00929, A13G-00930, A13G-00931, A13G-00932, A13G-00933, A13G-00934, A13G-00935, A13G-00936, A13G-00937, A13G-00938, A13G-00939, A13G-00940, A13G-00943, A13G-00944, A13G-00945, A13G-00946, A13G-00947, A13G-00948, A13G-00949, A13G-00950, A13G-00951, A13G-00952, A13G-00953, A13G-00954, 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A13G-01046, A13G-01047, A13G-01048, A13G-01049, A13G-01050, A13G-01051, A13G-01052, A13G-01053, A13G-01054, A13G-01055, A13G-01056, A13G-01057, A13G-01058, A13G-01059, A13G-01060, A13G-01061, A13G-01062, A13G-01063, A13G-01064, A13G-01065, A13G-01066, A13G-01067, A13G-01068, A13G-01069, A13G-01070, A13G-01072, A13G-01074, A13G-01077, A13G-01081, A13G-01086, A13G-01088, A13G-01090, A13G-01093, A13G-01107, A13G-01108, A13G-01109, A13G-01110, A13G-01111, A13G-01113, A13G-01131, A13G-01134, A13G-01136, A13G-01137, A13G-01138, A13G-01139, A13G-01140, A13G-01141, A13G-01142, A13G-01143, A13G-01144, A13G-01145, A13G-01146, A13G-01147, A13G-01148, A13G-01149, A13G-01150, A13G-01151, A13G-01152, A13G-01153, A13G-01154, A13G-01155, A13G-01156, A13G-01157, A13G-01158, A13G-01159, A13G-01160, A13G-01161, A13G-01162, A13G-01163, A13G-01164, A13G-01165, A13G-01167, A13G-01168, A13G-01169, A13G-01170, A13G-01171, A13G-01172, A13G-01173, A13G-01174, A13G-01175, A13G-01176, A13G-01177, A13G-01178, 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A13G-04468, A13G-04469, A13G-04473, A13G-04474, A13G-04475, A13G-04476, A13G-04477, A13G-04483, A13G-04484, A13G-04485, A13G-04486, A13G-04487, A13G-04488, A13G-04489, A13G-04490, A13G-04491, A13G-04493, A13G-04495, A13G-04496, A13G-04497, A13G-04498, A13G-04501, A13G-04502, A13G-04503, A13G-04504, A13G-04505, A13G-04506, A13G-04507, A13G-04508, A13G-04510, A13G-04511, A13G-04512, A13G-04513, A13G-04514, A13G-04515, A13G-04516, A13G-04517, A13G-04518, A13G-04519, A13G-04520, A13G-04521, A13G-04522, A13G-04525, A13G-04526, A13G-04527, A13G-04528, A13G-04529, A13G-04530, A13G-04531, A13G-04532, A13G-04533, A13G-04534, A13G-04535, A13G-04536, A13G-04537, A13G-04538, A13G-04539, A13G-04540, A13G-04541, A13G-04542, A13G-04543, A13G-04544, A13G-04545, A13G-04546, A13G-04547, A13G-04548, A13G-04549, A13G-04551, A13G-04552, A13G-04553, A13G-04554, A13G-04555, A13G-04556, A13G-04561, A13G-04562, A13G-04563, A13G-04565, A13G-04567, A13G-04568, A13G-04569, A13G-04570, A13G-04571, A13G-04572, 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A13G-05247, A13G-05250, A13G-05252, A13G-05253, A13G-05256, A13G-05257, A13G-05261, A13G-05262, A13G-05269, A13G-05270, A13G-05286, A13G-05288, A13G-05290, A13G-05291, A13G-05294, A13G-05296, A13G-05301, A13G-05308, A13G-05312, A13G-05313, A13G-05314, A13G-05316, A13G-05319, A13G-05321, A13G-05322, A13G-05326, A13G-05328, A13G-05329, A13G-05330, A13G-05331, A13G-05334, A13G-05336, A13G-05342, A13G-05343, A13G-05344, A13G-05346, A13G-05347, A13G-05349, A13G-05364, A13G-05365, A13G-05366, A13G-05367, A13G-05372, A13G-05374, A13G-05375, A13G-05386, A13G-05387, A13G-05388, A13G-05389, A13G-05390, A13G-05392, A13G-05393, A13G-05394, A13G-05395, A13G-05396, A13G-05397, A13G-05398, A13G-05406, A13G-05408, A13G-05409, A13G-05410, A13G-05411, A13G-05412, A13G-05420, A13G-05423, A13G-05427, A13G-05428, A13G-05429, A13G-05450, A13G-05451, A13G-05452, A13G-05454, A13G-05455, A13G-05460, A13G-05476, A13G-05489, A13G-05491, A13G-05495, A13G-05496, A13G-05497, A13G-05498, A13G-05499, A13G-05500, 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A13G-06198, A13G-06213, A13G-06214, A13G-06250, A13G-06251, A13G-06252, A13G-06253, A13G-06254, A13G-06255, A13G-06256, A13G-06257, A13G-06258, A13G-06311, A13G-06312, A13G-06313, A13G-06314, A13G-06315, A13G-06316, A13G-06317, A13G-06439, A13G-06440, A13G-06441, A13G-06442, A13G-06443, A13G-06446, A13G-06447, A13G-06448, A13G-06449, A13G-06450, A13G-06451, A13G-06452, A13G-06453, A13G-06455, A13G-06456, A13G-06458, A13G-06461, A13G-06462, A13G-06531, A13G-06534, A13G-06535, A13G-06536, A13G-06537, A13G-06538, A13G-06540, A13G-06541, A13G-06542, A13G-06546, A13G-06547, A13G-06548, A13G-06549, A13G-06551, A13G-06552, A13G-06553, A13G-06555, A13G-06557, A13G-06558, A13G-06559, A13G-06560, A13G-06561, A13G-06562, A13G-
Other Recalls from Philips Medical Systems North America...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1264-2014 | Class II | Philips Model EPIQ 7 Ultrasound System. Intend... | Feb 28, 2014 |
| Z-1263-2014 | Class II | Philips Model EPIQ 5 Ultrasound System. Intend... | Feb 28, 2014 |
| Z-1225-2014 | Class II | Philips HeartStart FR3 Automated External Defib... | Feb 6, 2014 |
| Z-0368-2014 | Class II | EPIQ 7 Ultrasound System, Model 795200, 795201,... | Oct 17, 2013 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.