Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manne...
FDA Device Recall #Z-1847-2019 — Class I — March 15, 2019
Recall Summary
| Recall Number | Z-1847-2019 |
| Classification | Class I — Serious risk |
| Date Initiated | March 15, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 28,094 units |
Product Description
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
Reason for Recall
The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.
Distribution Pattern
Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Guam, Northern Mariana Islands; and to countries of: Albania, Algeria, Argentina, Aruba, Australia, , Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Bolivia, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guam, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Korea (Republic of), Kuwait, Lebanon, Libya, Lithuania, Macau, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Moldova, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, STATE OF, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Lot / Code Information
Model Number, (Serial Number, UDI Number): M1112198-526438 (PBWX70184, 010084068210392321GBWX7012911180423); M1112198-526773 (PBWX71881, Not Applicable); M1112198-023402 (HDJQ51784, Not Applicable); M1112198-023402 (HDJQ51785, Not Applicable); M1112198-023402 (HDJQ51786, Not Applicable); M1112198-023402 (HDJQ51787, Not Applicable); M1112198-025399 (HDJR56841, Not Applicable); M1112198-025399 (HDJR56842, Not Applicable); M1112198-025399 (HDJR56843, Not Applicable); M1112198-025399 (HDJR56844, Not Applicable); M1112198-025399 (HDJR56845, Not Applicable); M1112198-025399 (HDJR56846, Not Applicable); M1112198-025399 (HDJR56847, Not Applicable); M1112198-025399 (HDJR56848, Not Applicable); M1112198-025399 (HDJR56849, Not Applicable); M1112198-025399 (HDJR56850, Not Applicable); M1112198-025399 (HDJR56851, Not Applicable); M1112198-025399 (HDJR56852, Not Applicable); M1112198-025399 (HDJR56853, Not Applicable); M1112198-165184 (HDJS50825, Not Applicable); M1112198-165184 (HDJS50826, Not Applicable); M1112198-165184 (HDJS50827, Not Applicable); M1112198-165184 (HDJS50828, Not Applicable); M1112198-165184 (HDJS50829, Not Applicable); M1112198-165184 (HDJS50830, Not Applicable); M1112198-165184 (HDJS50831, Not Applicable); M1112198-165184 (HDJS50832, Not Applicable); M1112198-183037 (HDJS53497, Not Applicable); M1112198-183037 (HDJS53498, Not Applicable); M1112198-183037 (HDJS53499, Not Applicable); M1112198-183037 (HDJS53500, Not Applicable); M1112198-183037 (HDJS53501, Not Applicable); M1112198-183037 (HDJS53502, Not Applicable); M1112198-183037 (HDJS53503, Not Applicable); M1112198-183037 (HDJS53504, Not Applicable); M1112198-183037 (HDJS53505, Not Applicable); M1112198-183037 (HDJS53506, Not Applicable); M1112198-183037 (HDJS53507, Not Applicable); M1112198-183037 (HDJS53508, Not Applicable); M1112198-033683 (HDJT51479, Not Applicable); M1112198-033683 (HDJT51480, Not Applicable); M1112198-496687 (PBWV60351, 010084068210389321PBWV6035111160615); M1112198-496687 (PBWV60436, 010084068210389321PBWV6043611160622); M1112198-023402 (HDJS50231, Not Applicable); M1112198-023402 (HDJS50232, Not Applicable); M1112198-023402 (HDJS50233, Not Applicable); M1112198-167403 (HDJU63124, Not Applicable); M1112198-167403 (HDJU63125, Not Applicable); M1112198-526395 (PBWX70345, 010084068210389321PBWX7034611180402); M1112198-526395 (PBWX70346, 010084068210389321PBWX7034711180402); M1112198-526395 (PBWX70347, 010084068210389321PBWX7034811180402); M1112198-526395 (PBWX70348, 010084068210389321PBWX7034911180403); M1112198-526395 (PBWX70349, 010084068210389321PBWX7035011180403); M1112198-526395 (PBWX70350, 010084068210389321PBWX7035111180403); M1112198-526395 (PBWX70351, Not Applicable); M1112198-526395 (PBWX70342, 010084068210389321PBWX7034311180329); M1112198-526395 (PBWX70343, 010084068210389321PBWX7034411180402); M1112198-526395 (PBWX70344, 010084068210389321PBWX7040611180412); M1112198-526395 (PBWX70406, 010084068210389321PBWX7040711180412); M1112198-526395 (PBWX70407, 010084068210389321PBWX7040811180412); M1112198-526395 (PBWX70408, 010084068210389321PBWX7040911180413); M1112198-526395 (PBWX70409, 010084068210389321PBWW6267111171107); M1112198-526395 (PBWX70490, 010084068210389321PBWX7049111180430); M1112198-526395 (PBWX70491, 010084068210389321PBWX7049211180430); M1112198-526395 (PBWX70492, 010084068210389321PBWX7049411180430); M1112198-526395 (PBWX70494, 010084068210389321PBWX7049511180430); M1112198-526395 (PBWX70495, Not Applicable); M1112198-036338 (HDJR58037, Not Applicable); M1112198-036338 (HDJR58038, Not Applicable); M1112198-493228 (PBWV60691, 010084068210389321PBWV6069111160727); M1112198-022718 (HDJR56364, Not Applicable); M1112198-187066 (HDJS51373, Not Applicable); M1112198-187066 (HDJS51374, Not Applicable); M1112198-187066 (HDJS51386, Not Applicable); M1112198-195382 (HDJS55123, Not Applicable); M1112198-170328 (HDJT61450, Not Applicable); M1112198-170328 (HDJT61451, Not Applicable); M1112198-184659 (HDJT51191, Not Applicable); M1112198-184659 (HDJT62177, Not Applicable); M1112198-023402 (HDJR56425, Not Applicable); M1112198-023402 (HDJR56426, Not Applicable); M1112198-023402 (HDJR56427, Not Applicable); M1112198-023402 (HDJR56428, Not Applicable); M1112198-526773 (PBWX60678, Not Applicable); M1112198-022592 (HDJL50018, Not Applicable); M1112198-023848 (HDJQ51132, Not Applicable); M1112198-167403 (HDJS51729, Not Applicable); M1112198-164657 (HDJU60297, Not Applicable); M1112198-191821 (HDJU63220, Not Applicable); M1112198-191821 (HDJU63221, Not Applicable); M1112198-554475 (PBWX70261, Not Applicable); M1112198-527554 (PBWW61336, 010084068210389321PBWW6133611170519); M1112198-163959 (HDJU63168, Not Applicable); M1112198-512500 (PBWV60952, 010084068210389321PBWV6095211160909); M1112198-514719 (PBWV61193, 010084068210389321PBWV6119311161007); M1112198-024549 (HDJU60791, Not Applicable); M1112198-163959 (HDJU61714, Not Applicable); M1112198-163959 (HDJU61715, Not Applicable); M1112198-025180 (HDJP50570, Not Applicable); M1112198-080677 (HDJM50048, Not Applicable); M1112198-080677 (HDJP50680, Not Applicable); M1112198-026465 (HDJR54038, Not Applicable); M1112198-026465 (HDJR54039, Not Applicable); M1112198-026465 (HDJR54040, Not Applicable); M1112198-026465 (HDJR54041, Not Applicable); M1112198-026465 (HDJR54042, Not Applicable); M1112198-026465 (HDJR54043, Not Applicable); M1112198-026465 (HDJR54044, Not Applicable); M1112198-026465 (HDJR54045, Not Applicable); M1112198-026465 (HDJR54046, Not Applicable); M1112198-022592 (HDJR56925, Not Applicable); M1112198-022592 (HDJR56926, Not Applicable); M1112198-022592 (HDJR56927, Not Applicable); M1112198-164657 (HDJS50958, Not Applicable); M1112198-164657 (HDJS50959, Not Applicable); M1112198-164657 (HDJS50960, Not Applicable); M1112198-164657 (HDJS50961, Not Applicable); M1112198-164657 (HDJS50962, Not Applicable); M1112198-164657 (HDJS50963, Not Applicable); M1112198-164657 (HDJT50500, Not Applicable); M1112198-164657 (HDJT50678, Not Applicable); M1112198-164657 (HDJT50679, Not Applicable); M1112198-164657 (HDJT50680, Not Applicable); M1112198-164657 (HDJT50681, Not Applicable); M1112198-164657 (HDJT50683, Not Applicable); M1112198-164657 (HDJT50684, Not Applicable); M1112198-164657 (HDJT50685, Not Applicable); M1112198-164256 (HDJU61892, Not Applicable); M1112198-164256 (HDJU61899, Not Applicable); M1112198-164256 (HDJU61900, Not Applicable); M1112198-164256 (HDJU61901, Not Applicable); M1112198-389186 (HDJU61637, Not Applicable); M1112198-389186 (HDJU61638, Not Applicable); M1112198-389186 (HDJU61639, Not Applicable); M1112198-164256 (HDJU61557, Not Applicable); M1112198-164256 (HDJU61558, Not Applicable); M1112198-024549 (HDJU65796, Not Applicable); M1112198-080677 (HDJM50528, Not Applicable); M1112198-080677 (HDJP50937, Not Applicable); M1112198-080677 (HDJL50023, Not Applicable); M1112198-080677 (HDJQ51829, Not Applicable); M1112198-080677 (HDJN51934, Not Applicable); M1112198-080677 (HDJM50529, Not Applicable); M1112198-025967 (HDJN50599, Not Applicable); M1112198-047244 (HDJP50935, Not Applicable); M1112198-047244 (HDJQ50105, Not Applicable); M1112198-196063 (HDJS52177, Not Applicable); M1112198-196063 (HDJS52178, Not Applicable); M1112198-196063 (HDJS52179, Not Applicable); M1112198-196063 (HDJS52180, Not Applicable); M1112198-196063 (HDJS52181, Not Applicable); M1112198-196063 (HDJT61514, Not Applicable); M1112198-043775 (HDJN52474, Not Applicable); M1112198-043775 (HDJN52475, Not Applicable); M1112198-027124 (HDJP50065, Not Applicable); M1112198-027124 (HDJP50073, Not Applicable); M1112198-027124 (HDJP50074, Not Applicable); M1112198-027124 (HDJP50075, Not Applicable); M1112198-027124 (HDJP50076, Not Applicable); M1112198-027124 (HDJP50077, Not Applicable); M1112198-497954 (PBWV60158, 010084068210389321PBWV6015811160527); M1112198-497954 (PBWV60159, 010084068210389321PBWV6015911160527); M1112198-497954 (PBWV60160, 010084068210389321PBWV6016011160527); M1112198-497954 (PBWV60357, 010084068210389321PBWV6035711160616); M1112198-029424 (HDJN51927, Not Applicable); M1112198-024139 (HDJM50047, Not Applicable); M1112198-527596 (PBWW60981, 010084068210389321PBWW6098111170421); M1112198-527596 (PBWW60982, 010084068210389321PBWW6098211170421); M1112198-527596 (PBWW60983, 010084068210389321PBWW6098311170421); M1112198-527596 (PBWW60985, 010084068210389321PBWW6098511170421); M1112198-527596 (PBWW60986, 010084068210389321PBWW6098611170421); M1112198-527596 (PBWW60987, 010084068210389321PBWW6098711170421); M1112198-527596 (PBWW60988, 010084068210389321PBWW6098811170421); M1112198-527596 (PBWW60989, 010084068210389321PBWW6098911170421); M1112198-527596 (PBWW60990, 010084068210389321PBWW6099011170421); M1112198-527596 (PBWW60991, 010084068210389321PBWW6099111170421); M1112198-527596 (PBWW60992, 010084068210389321PBWW6099211170421); M1112198-527596 (PBWW60993, 010084068210389321PBWW6099311170421); M1112198-024198 (HDJM52142, Not Applicable); M1112198-024417 (HDJN51700, Not Applicable); M1112198-526395 (PBWW60674, 010084068210389321PBWW6067411170321); M1112198-068135 (HDJQ50378, Not Applicable); M1112198-068135 (HDJQ50379, Not Applicable); M1112198-181217 (HDJS50434, Not Applicable); M1112198-526395 (PBWX71746, 010084068210389321PBWX7174711180912); M1112198-526395 (PBWX71747, 010084068210389321PBWX7174811180912); M1112198-526395 (PBWX71748, 010084068210389321PBWX7174911180912); M1112198-526395 (PBWX71749, 010084068210389321PBWX7175011180913); M1112198-526395 (PBWX71750, 010084068210389321PBWX7175111180913); M1112198-526395 (PBWX71751, 010084068210389321PBWX7175211180913); M1112198-526395 (PBWX71752, Not Applicable); M1112198-029424 (HDJN51904, Not Applicable); M1112198-029424 (HDJN51907, Not Applicable); M1112198-029424 (HDJN51991, Not Applicable); M1112198-029424 (HDJN51997, Not Applicable); M1112198-023488 (HDJR57247, Not Applicable); M1112198-023488 (HDJR57248, Not Applicable); M1112198-033981 (HDJR56682, Not Applicable); M1112198-229362 (HDJU63263, Not Applicable); M1112198-527554 (PBWW61599, 010084068210389321PBWW6169011170630); M1112198-527554 (PBWW61690, 010084068210389321PBWW6169111170630); M1112198-527554 (PBWW61691, 010084068210389321PBWW6169211170630); M1112198-527554 (PBWW61692, 010084068210389321PBWW6169311170630); M1112198-527554 (PBWW61693, 010084068210389321PBWW6171911170711); M1112198-527554 (PBWW61719, 010084068210389321PBWW6172011170711); M1112198-527554 (PBWW61720, 010084068210389321PBWW6172111170711); M1112198-527554 (PBWW61721, 010084068210389321PBWW6172311170711); M1112198-527554 (PBWW61723, 010084068210389321PBWW6172511170711); M1112198-527554 (PBWW61725, 010084068210389321PBWW6172611170711); M1112198-527554 (PBWW61726, 010084068210389321PBWW6173111170711); M1112198-527554 (PBWW61731, 010084068210389321PBWW6173311170711); M1112198-527554 (PBWW61733, 010084068210389321PBWW6173511170711); M1112198-527554 (PBWW61735, 010084068210389321PBWW6173611170711); M1112198-527554 (PBWW61736, 010084068210389321PBWW6173911170711); M1112198-527554 (PBWW61739, 010084068210389321PBWW6174111170711); M1112198-527554 (PBWW61741, 010084068210389321PBWW6190511170724); M1112198-527554 (PBWW61905, 010084068210389321PBWW6198311170801); M1112198-527554 (PBWW61983, 010084068210389321PBWW6198611170801); M1112198-527554 (PBWW61986, 010084068210389321PBWW6199211170801); M1112198-527554 (PBWW61992, 010084068210389321PBWW6229711170914); M1112198-527554 (PBWW62297, 010084068210392321GBWW6051711170711); M1112198-029424 (HDJN52007, Not Applicable); M1112198-023488 (HDJQ52246, Not Applicable); M1112198-023488 (HDJQ52248, Not Applicable); M1112198-023488 (HDJQ52249, Not Applicable); M1112198-023488 (HDJQ52250, Not Applicable); M1112198-023488 (HDJQ52251, Not Applicable); M1112198-023488 (HDJQ52252, Not Applicable); M1112198-023488 (HDJQ52253, Not Applicable); M1112198-023488 (HDJQ52255, Not Applicable); M1112198-023488 (HDJQ52257, Not Applicable); M1112198-023488 (HDJQ52258, Not Applicable); M1112198-023488 (HDJQ52260, Not Applicable); M1112198-023488 (HDJQ52261, Not Applicable); M1112198-057955 (HDJR56902, Not Applicable); M1112198-496036 (PBWV61306, 010084068210389321PBWV6130611161102); M1112198-496036 (PBWV61307, 010084068210389321PBWV6130711161102); M1112198-562296 (PBWX71281, 010084068210389321PBWX7128211180724); M1112198-562296 (PBWX71282, 010084068210389321PBWX7128311180724); M1112198-562296 (PBWX71283, 010084068210389321PBWX7129011180725); M1112198-562298 (PBWX71290, 010084068210389321PBWX7129511180725); M1112198-562298 (PBWX71295, 010084068210389321PBWX7210311181019); M1112198-562298 (PBWX72103, 010084068210389321PBWX7210411181019); M1112198-562298 (PBWX72104, 010084068210389321PBWX7210511181019); M1112198-562298 (PBWX72105, 010084068210389321PBWX7210811181019); M1112198-562298 (PBWX72108, Not Applicable); M1112198-513789 (PBWV61084, 010084068210389321PBWV6108411160927); M1112198-526395 (PBWX71703, Not Applicable); M1112198-022996 (HDJP52286, Not Applicable); M1112198-022996 (HDJP52287, Not Applicable); M1112198-022996 (HDJP52288, Not Applicable); M1112198-028964 (HDJR50053, Not Applicable); M1112198-028964 (HDJR50054, Not Applicable); M1112198-028964 (HDJR50055, Not Applicable); M1112198-028964 (HDJR50056, Not Applicable); M1112198-024139 (HDJL50026, Not Applicable); M1112198-024139 (HDJM50596, Not Applicable); M1112198-024139 (HDJQ50744, Not Applicable); M1112198-024139 (HDJQ50819, Not Applicable); M1112198-033683 (HDJR57142, Not Applicable); M1112198-033683 (HDJR57143, Not Applicable); M1112198-033683 (HDJR57144, Not Applicable); M1112198-023595 (HDJT60667, Not Applicable); M1112198-191821 (HDJU61765, Not Applicable); M1112198-191821 (HDJU61766, Not Applicable); M1112198-191821 (HDJU61767, Not Applicable); M1112198-191821 (HDJU61768, Not Applicable); M1112198-526438 (PBWW60940, 010084068210389321PBWW6094011170418); M1112198-526438 (PBWW60948, 010084068210389321PBWW6094811170418); M1112198-526438 (PBWW60953, 010084068210389321PBWW6095311170418); M1112198-526438 (PBWW60954, 010084068210389321PBWW6095411170418); M1112198-529782 (PBWX71209, 010084068210389321PBWX7132711180730); M1112198-022996 (HDJN52403, Not Applicable); M1112198-022996 (HDJN52404, Not Applicable); M1112198-022996 (HDJN52405, Not Applicable); M1112198-022996 (HDJN52406, Not Applicable); M1112198-022996 (HDJN52407, Not Applicable); M1112198-043633 (HDJP52481, Not Applicable); M1112198-043633 (HDJP52482, Not Applicable); M1112198-034157 (HDJP52722, Not Applicable); M1112198-034157 (HDJP52723, Not Applicable); M1112198-034157 (HDJP52724, Not Applicable); M1112198-164657 (HDJT60080, Not Applicable); M1112198-184659 (HDJT60461, Not Applicable); M1112198-169702 (HDJU61543, Not Applicable); M1112198-169702 (HDJU61544, Not Applicable); M1112198-169702 (HDJU61545, Not Applicable); M1112198-169702 (HDJU61547, Not Applicable); M1112198-169702 (HDJU61548, Not Applicable); M1112198-169702 (HDJU61549, Not Applicable); M1112198-169702 (HDJU61550, Not Applicable); M1112198-169702 (HDJU61566, Not Applicable); M1112198-496687 (HDJV61314, 010084068210389321HDJV6131411160510); M1112198-496687 (PBWV60016, 010084068210389321PBWV6001611160518); M1112198-183037 (HDJT50427, Not Applicable); M1112198-169702 (HDJU65544, Not Applicable); M1112198-169702 (HDJU65545, Not Applicable); M1112198-169702 (HDJU65546, Not Applicable); M1112198-169702 (HDJU66282, Not Applicable); M1112198-529782 (PBWX70920, 010084068210389321PBWX7092111180625); M1112198-529782 (PBWX70921, 010084068210389321PBWX7092211180625); M1112198-529782 (PBWX70922, 010084068210389321PBWX7092311180625); M1112198-529782 (PBWX70923, 010084068210389321PBWX7092411180625); M1112198-529782 (PBWX70924, 010084068210389321PBWX7093411180625); M1112198-191821 (HDJU61662, Not Applicable); M1112198-176364 (HDJS50857, Not Applicable); M1112198-176364 (HDJS50858, Not Applicable); M1112198-025967 (HDJM51235, Not Applicable); M1112198-025967 (HDJM51303, Not Applicable); M1112198-047244 (HDJP51372, Not Applicable); M1112198-052730 (HDJP51655, Not Applicable); M1112198-052730 (HDJP51656, Not Applicable); M1112198-084839 (HDJQ51983, Not Applicable); M1112198-526395 (PBWW60632, 010084068210389321PBWW6063211170316); M1112198-526395 (PBWW60641, 010084068210389321PBWW6064111170316); M1112198-526395 (PBWW60673, 010084068210389321PBWW6067311170321); M1112198-527362 (PBWW61411, 010084068210389321PBWW6141111170531); M1112198-527362 (PBWW61412, 010084068210389321PBWW6141211170531); M1112198-527362 (PBWX71520, 010084068210389321PBWX7182911180921); M1112198-532026 (PBWX72867, 010084068210389321PBWX7286811181228); M1112198-532026 (PBWX72868, 010084068210389321PBWY7002411190103); M1112198-036139 (HDJP51863, Not Applicable); M1112198-036139 (HDJP51864, Not Applicable); M1112198-020566 (HDJL50397, Not Applicable); M1112198-020566 (HDJL50398, Not Applicable); M1112198-020566 (HDJL50399, Not Applicable); M1112198-020566 (HDJL50400, Not Applicable); M1112198-498952 (PBWV60860, 010084068210389321PBWV6086011160831); M1112198-498952 (PBWV60861, 010084068210389321PBWV6086111160831); M1112198-498952 (PBWV60862, 010084068210389321PBWV6086211160831); M1112198-498952 (PBWV60863, 010084068210389321PBWV6086311160831); M1112198-498952 (PBWV60864, 010084068210389321PBWV6086411160831); M1112198-498952 (PBWV60865, 010084068210389321PBWV6086511160831); M1112198-498952 (PBWV60866, 010084068210389321PBWV6086611160831); M1112198-498952 (PBWV60867, 010084068210389321PBWV6086711160831); M1112198-498952 (PBWV60868, 010084068210389321PBWV6086811160831); M1112198-498952 (PBWV60869, 010084068210389321PBWV6086911160831); M1112198-498952 (PBWV60870, 010084068210389321PBWV6087011160831); M1112198-498952 (PBWV60871, 010084068210389321PBWV6087111160831); M1112198-023359 (HDJR50373, Not Applicable); M1112198-023359 (HDJR50374, Not Applicable); M1112198-023359 (HDJR50375, Not Applicable); M1112198-023359 (HDJR50376, Not Applicable); M1112198-023359 (HDJR50377, Not Applicable); M1112198-023359 (HDJR50378, Not Applicable); M1112198-023359 (HDJR50379, Not Applicable); M1112198-023359 (HDJR50380, Not Applicable); M1112198-023359 (HDJR50381, Not Applicable); M1112198-023359 (HDJR50382, Not Applicable); M1112198-023359 (HDJR50383, Not Applicable); M1112198-023359 (HDJR50384, Not Applicable); M1112198-023359 (HDJR50385, Not Applicable); M1112198-023359 (HDJR50386, Not Applicable); M1112198-023359 (HDJR50387, Not Applicable); M1112198-023359 (HDJR50388, Not Applicable); M1112198-023359 (HDJR50389, Not Applicable); M1112198-023359 (HDJR50390, Not Applicable); M1112198-165121 (HDJU61893, Not Applicable); M1112198-164256 (HDJV60508, Not Applicable); M1112198-164256 (HDJV60509, Not Applicable); M1112198-164256 (HDJV60576, Not Applicable); M1112198-497258 (PBWV60636, 010084068210389321PBWV6063611160722); M1112198-497258 (PBWV60737, 010084068210389321PBWV6073711160803); M1112198-497258 (PBWV60738, 010084068210389321PBWV6073811160803); M1112198-497258 (PBWV60739, 010084068210389321PBWV6073911160803); M1112198-497258 (PBWV60740, 010084068210389321PBWV6074011160803); M1112198-497258 (PBWV60765, 010084068210389321PBWV6076511160808); M1112198-497258 (PBWV60766, 010084068210389321PBWV6076611160808); M1112198-497258 (PBWV60767, 010084068210389321PBWV6076711160808); M1112198-497258 (PBWV60768, 010084068210389321PBWV6076811160808); M1112198-497258 (PBWV60769, 010084068210389321PBWV6076911160808); M1112198-497258 (PBWV60805, 010084068210389321PBWV6080511160811); M1112198-497258 (PBWV60808, 010084068210389321PBWV6080811160811); M1112198-497258 (PBWV60809, 010084068210389321PBWV6080911160811); M1112198-497258 (PBWV60810, 010084068210389321PBWV6081011160811); M1112198-497258 (PBWV61013, 010084068210389321PBWV6101311160919); M1112198-497258 (PBWV61014, 010084068210389321PBWV6101411160919); M1112198-497258 (PBWV61015, 010084068210389321PBWV6101511160919); M1112198-497258 (PBWV61016, 010084068210389321PBWV6101611160919); M1112198-497258 (PBWV61017, 010084068210389321PBWV6101711160919); M1112198-497258 (PBWV61018, 010084068210389321PBWV6101811160919); M1112198-497258 (PBWV61020, 010084068210389321PBWV6102011160919); M1112198-497258 (PBWV61022, 010084068210389321PBWV6102211160919); M1112198-497258 (PBWV61023, 010084068210389321PBWV6102311160919); M1112198-497258 (PBWV61112, 010084068210389321PBWV6111211160928); M1112198-526437 (PBWX72674, 010084068210389321PBWX7275311181217); M1112198-043212 (HDJN52395, Not Applicable); M1112198-043212 (HDJN52396, Not Applicable); M1112198-043212 (HDJN52397, Not Applicable); M1112198-043212 (HDJN52398, Not Applicable); M1112198-038368 (HDJP50595, Not Applicable); M1112198-038368 (HDJP50607, Not Applicable); M1112198-038368 (HDJP50608, Not Applicable); M1112198-038368 (HDJP50610, Not Applicable); M1112198-024549 (HDJU60385, Not Applicable); M1112198-024549 (HDJU60386, Not Applicable); M1112198-022794 (HDJU61936, Not Applicable); M1112198-026513 (HDJN52172, Not Applicable); M1112198-026513 (HDJN52173, Not Applicable); M1112198-024660 (HDJT60726, Not Applicable); M1112198-024660 (HDJT60727, Not Applicable); M1112198-024660 (HDJT60728, Not Applicable); M1112198-024660 (HDJT60729, Not Applicable); M1112198-024660 (HDJT60730, Not Applicable); M1112198-171607 (HDJS50605, Not Applicable); M1112198-171607 (HDJS50606, Not Applicable); M1112198-179222 (HDJS50954, Not Applicable); M1112198-179222 (HDJS50955, Not Applicable); M1112198-160247 (HDJS52190, Not Applicable); M1112198-160247 (HDJS52191, Not Applicable); M1112198-160247 (HDJS52192, Not Applicable); M1112198-160247 (HDJS52193, Not Applicable); M1112198-160247 (HDJS52194, Not Applicable); M1112198-160247 (HDJS52195, Not Applicable); M1112198-160247 (HDJS52196, Not Applicable); M1112198-160247 (HDJS52197, Not Applicable); M1112198-160247 (HDJS52198, Not Applicable); M1112198-160247 (HDJS52199, Not Applicable); M1112198-160247 (HDJS52200, Not Applicable); M1112198-160247 (HDJS52201, Not Applicable); M1112198-160247 (HDJS52202, Not Applicable); M1112198-160247 (HDJS52203, Not Applicable); M1112198-160247 (HDJS52204, Not Applicable); M1112198-160247 (HDJS52205, Not Applicable); M1112198-160247 (HDJS52206, Not Applicable); M1112198-160247 (HDJS52207, Not Applicable); M1112198-160247 (HDJS52208, Not Applicable); M1112198-160247 (HDJS52209, Not Applicable); M1112198-179222 (HDJT62092, Not Applicable); M1112198-498952 (PBWV60023, 010084068210389321PBWV6002311160518); M1112198-498952 (PBWV60024, 010084068210389321PBWV6002411160518); M1112198-498952 (PBWV60025, 010084068210389321PBWV6002511160518); M1112198-027240 (HDJR50214, Not Applicable); M1112198-027240 (HDJR50215, Not Applicable); M1112198-024549 (HDJP52464, Not Applicable); M1112198-533898 (PBWW61231, 010084068210389321PBWW6123111170515); M1112198-533898 (PBWW61232, 010084068210389321PBWW6123211170515); M1112198-529782 (PBWX72814, 010084068210389321PBWX7281111181220); M1112198-022943 (HDJM50397, Not Applicable); M1112198-022943 (HDJM50398, Not Applicable); M1112198-022943 (HDJM50399, Not Applicable); M1112198-022943 (HDJM50400, Not Applicable); M1112198-022943 (HDJM50401, Not Applicable); M1112198-022943 (HDJM50402, Not Applicable); M1112198-026108 (HDJP50574, Not Applicable); M1112198-025813 (HDJP51681, Not Applicable); M1112198-025813 (HDJP51682, Not Applicable); M1112198-025828 (HDJQ52007, Not Applicable); M1112198-023429 (HDJR56619, Not Applicable); M1112198-023429 (HDJR56620, Not Applicable); M1112198-024089 (HDJU65928, Not Applicable); M1112198-024089 (HDJU65929, Not Applicable); M1112198-024089 (HDJU65930, Not Applicable); M1112198-024089 (HDJU65931, Not Applicable); M1112198-503251 (PBWV60507, 010084068210389321PBWV6050711160707); M1112198-503251 (PBWV61279, 010084068210389321PBWV6127911161024); M1112198-022943 (HDJN51106, Not Applicable); M1112198-022943 (HDJN51107, Not Applicable); M1112198-022943 (HDJN51108, Not Applicable); M1112198-547087 (PBWW62591, 010084068210389321PBWW6259211171020); M1112198-547087 (PBWW62592, 010084068210389321PBWW6259311171020); M1112198-547087 (PBWW62593, 010084068210389321PBWW6259411171020); M1112198-547087 (PBWW62594, 010084068210389321PBWW6259611171020); M1112198-547087 (PBWW62596, 010084068210389321PBWW6259711171020); M1112198-547087 (PBWW62597, 010084068210389321PBWW6187511170724); M1112198-031960 (HDJP50031, Not Applicable); M1112198-185539 (HDJS51280, Not Applicable); M1112198-535389 (PBWW62588, 010084068210389321PBWW6258911171020); M1112198-535389 (PBWW62589, 010084068210389321PBWX7001711180110); M1112198-547087 (PBWW62590, 010084068210389321PBWW6259511171020); M1112198-547087 (PBWW62595, Not Applicable); M1112198-527596 (PBWX60784, 010084068210389321PBWX6073711180628); M1112198-022718 (HDJM51260, Not Applicable); M1112198-022718 (HDJM51261, Not Applicable); M1112198-022718 (HDJM51263, Not Applicable); M1112198-022718 (HDJM51267, Not Applicable); M1112198-022718 (HDJN51606, Not Applicable); M1112198-022718 (HDJN51803, Not Applicable); M1112198-022718 (HDJN51804, Not Applicable); M1112198-022718 (HDJN51806, Not Applicable); M1112198-022718 (HDJN51807, Not Applicable); M1112198-179222 (HDJS53461, Not Applicable); M1112198-179222 (HDJS53462, Not Applicable); M1112198-179222 (HDJS53464, Not Applicable); M1112198-179222 (HDJS55098, Not Applicable); M1112198-526437 (PBWX70484, 010084068210389321PBWX7048511180427); M1112198-526437 (PBWX70485, 010084068210389321PBWX7048611180427); M1112198-526437 (PBWX70486, 010084068210389321PBWX6034611180328); M1112198-025813 (HDJR54118, Not Applicable); M1112198-025813 (HDJR54119, Not Applicable); M1112198-025813 (HDJR54120, Not Applicable); M1112198-025813 (HDJR56052, Not Applicable); M1112198-526394 (PBWW63044, 010084068210389321PBWW6304511171227); M1112198-526394 (PBWW63045, 010084068210389321PBWW6304611171227); M1112198-526394 (PBWW63046, 010084068210389321PBWW6304711171227); M1112198-526394 (PBWW63047, 010084068210392321GBWW6096811171218); M1112198-024089 (HDJS51977, Not Applicable); M1112198-024089 (HDJS51978, Not Applicable); M1112198-042554 (HDJT60659, Not Applicable); M1112198-042554 (HDJU61478, Not Applicable); M1112198-025440 (HDJM51049, Not Applicable); M1112198-024089 (HDJM51243, Not Applicable); M1112198-044472 (HDJP51417, Not Applicable); M1112198-030805 (HDJR54116, Not Applicable); M1112198-194022 (HDJS51995, Not Applicable); M1112198-194022 (HDJS51996, Not Applicable); M1112198-194022 (HDJS51999, Not Applicable); M1112198-194022 (HDJS52000, Not Applicable); M1112198-229362 (HDJU61395, Not Applicable); M1112198-529782 (PBWW62728, 010084068210389321PBWW6224911170911); M1112198-529782 (PBWX70193, 010084068210389321PBWX7019411180306); M1112198-529782 (PBWX70194, 010084068210389321PBWX7022111180308); M1112198-164335 (HDJT61898, Not Applicable); M1112198-164335 (HDJT61900, Not Applicable); M1112198-529782 (PBWW61008, 010084068210389321PBWW6100811170427); M1112198-529782 (PBWW61273, 010084068210389321PBWW6127311170517); M1112198-529782 (PBWW61517, 010084068210389321PBWW6151711170612); M1112198-529782 (PBWW61520, 010084068210389321PBWW6200011170802); M1112198-024781 (HDJQ50034, Not Applicable); M1112198-024781 (HDJQ50035, Not Applicable); M1112198-533898 (PBWX71729, 010084068210389321PBWX7174311180912); M1112198-024781 (HDJP51953, Not Applicable); M1112198-024781 (HDJP51954, Not Applicable); M1112198-024781 (HDJP51955, Not Applicable); M1112198-506366 (PBWV60411, 010084068210389321PBWV6041111160620); M1112198-052019 (HDJR50486, Not Applicable); M1112198-052019 (HDJR50487, Not Applicable); M1112198-052019 (HDJR50488, Not Applicable); M1112198-052019 (HDJR50489, Not Applicable); M1112198-052019 (HDJR50490, Not Applicable); M1112198-052019 (HDJR50491, Not Applicable); M1112198-032958 (HDJN50211, Not Applicable); M1112198-052202 (HDJQ51545, Not Applicable); M1112198-166879 (HDJS51721, Not Applicable); M1112198-028826 (HDJM51903, Not Applicable); M1112198-028826 (HDJM51904, Not Applicable); M1112198-493228 (PBWV60877, 010084068210389321PBWV6087711160901); M1112198-497954 (PBWW60486, 010084068210389321PBWW6048611170301); M1112198-497954 (PBWW61402, 010084068210389321PBWW6140211170531); M1112198-497954 (PBWW61403, 010084068210389321PBWW6140311170531); M1112198-497954 (PBWW61404, 010084068210389321PBWW6140411170531); M1112198-497954 (PBWW61405, 010084068210389321PBWW6140511170531); M1112198-497954 (PBWW61406, 010084068210389321PBWW6140611170531); M1112198-497954 (PBWW61407, 010084068210389321PBWW6140711170531); M1112198-497954 (PBWW61408, 010084068210389321PBWW6140811170531); M1112198-497954 (PBWW61409, 010084068210389321PBWW6140911170531); M1112198-497954 (PBWW61410, 010084068210389321PBWW6141011170531); M1112198-165121 (HDJU60611, Not Applicable); M1112198-497022 (PBWV60844, 010084068210389321PBWV6084411160830); M1112198-164657 (HDJT51749, Not Applicable); M1112198-026108 (HDJQ51939, Not Applicable); M1112198-026108 (HDJQ51940, Not Applicable); M1112198-026108 (HDJQ51941, Not Applicable); M1112198-026108 (HDJQ51942, Not Applicable); M1112198-023791 (HDJR50442, Not Applicable); M1112198-164657 (HDJS51888, Not Applicable); M1112198-493228 (HDJV60882, Not Applicable); M1112198-527790 (PBWX70653, 010084068210389321PBWX7065411180521); M1112198-527790 (PBWX70654, 010084068210389321PBWX7065511180521); M1112198-527790 (PBWX70655, 010084068210389321PBWX7065611180521); M1112198-527790 (PBWX70656, 010084068210389321PBWX6036911180403); M1112198-018105 (HDJM50138, Not Applicable); M1112198-018105 (HDJM50139, Not Applicable); M1112198-018105 (HDJM50140, Not Applicable); M1112198-023608 (HDJN50393, Not Applicable); M1112198-023608 (HDJN50394, Not Applicable); M1112198-023608 (HDJN50395, Not Applicable); M1112198-024585 (HDJP50985, Not Applicable); M1112198-024585 (HDJP50990, Not Applicable); M1112198-024585 (HDJP50991, Not Applicable); M1112198-026465 (HDJP52693, Not Applicable); M1112198-026465 (HDJP52694, Not Applicable); M1112198-023608 (HDJQ51090, Not Applicable); M1112198-023608 (HDJQ51091, Not Applicable); M1112198-024585 (HDJM50471, Not Applicable); M1112198-171606 (HDJS50986, Not Applicable); M1112198-171606 (HDJT50381, Not Applicable); M1112198-171606 (HDJT60397, Not Applicable); M1112198-024585 (HDJP51432, Not Applicable); M1112198-526773 (PBWW61311, 010084068210389321PBWW6207111170816); M1112198-526773 (PBWW62071, 010084068210389321PBWW6207411170816); M1112198-169702 (HDJT60035, Not Applicable); M1112198-173419 (HDJT62093, Not Applicable); M1112198-173419 (HDJT62094, Not Applicable); M1112198-025615 (HDJM51024, Not Applicable); M1112198-022996 (HDJM51159, Not Applicable); M1112198-022996 (HDJM51160, Not Applicable); M1112198-022996 (HDJM51161, Not Applicable); M1112198-022996 (HDJM51162, Not Applicable); M1112198-022996 (HDJM51163, Not Applicable); M1112198-022996 (HDJM51164, Not Applicable); M1112198-022996 (HDJM51165, Not Applicable); M1112198-022996 (HDJM51166, Not Applicable); M1112198-022996 (HDJM51167, Not Applicable); M1112198-025874 (HDJM51131, Not Applicable); M1112198-025874 (HDJM51132,
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.