Home / Recalls / GE Healthcare, LLC / Z-1847-2019

Z-1847-2019 Class I Terminated

Recalled by GE Healthcare, LLC — Waukesha, WI

FDA device recall Z-1847-2019 was initiated by GE Healthcare, LLC on March 15, 2019 and is designated Class I. 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 ha… The recall status is terminated (terminated May 21, 2024). Affected quantity: 28,094 units.

Recall Details

Product Type
Devices
Report Date
July 17, 2019
Initiation Date
March 15, 2019
Termination Date
May 21, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product 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.

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 by GE Healthcare, LLC

  • Z-1767-2026 Class II — SIGNA Premier systems (February 27, 2026)
  • Z-1475-2026 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: (January 16, 2026)
  • Z-0935-2026 Class II — GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin (November 3, 2025)
  • Z-1484-2025 Class II — GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; (February 19, 2025)
  • Z-1486-2025 Class II — GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203390 (February 19, 2025)
  • Z-1487-2025 Class II — GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers (February 19, 2025)
  • Z-1483-2025 Class II — GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; (February 19, 2025)
  • Z-1485-2025 Class II — GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-0 (February 19, 2025)
  • Z-0318-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2 (October 3, 2024)
  • Z-0039-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/C (August 29, 2024)

FDA data resources