FDA · Medical device recall

Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared… and 1 more product

July 17, 2019 Class I

Date: July 17, 2019
Risk class: Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: 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.

2 products in this recall

Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates…

Product: Giraffe 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.
Quantity: 9,094 devices
Codes and lots: Model Number, (Serial Number, UDI Number): M1118179-529707 (GBWW60444, 010084068210392321GBWW6044411170620); M1118179-529707 (GBWW60446, 010084068210392321GBWW6044611170620); M1118179-024201 (HDJM50619, Not Applicable); M1118179-024201 (HDJM50620, Not Applicable); M1118179-025977 (HDJN50298, Not Applicable); M1118179-025977 (HDJN50299, Not Applicable); M1118179-029089 (HDJP50554, Not Applicable); M1118179-029089 (HDJP50555, Not Applicable); M1118179-038813 (HDJR54214, Not Applicable); M1118179-038813 (HDJR54215, Not Applicable); M1118179-038813 (HDJR54216, Not Applicable); M1118179-024011 (HDJS50551, Not Applicable); M1118179-024011 (HDJS50552, Not Applicable); M1118179-024011 (HDJS50553, Not Applicable); M1118179-024011 (HDJS50554, Not Applicable); M1118179-024011 (HDJS50555, Not Applicable); M1118179-150421 (HDJU61285, Not Applicable); M1118179-150421 (HDJU61286, Not Applicable); M1118179-150421 (HDJU61287, Not Applicable); M1118179-150421 (HDJS52930, Not Applicable); M1118179-150421 (HDJS52931, Not Applicable); M1118179-150421 (HDJS52933, Not Applicable); M1118179-150421 (HDJS55007, Not Applicable); M1118179-150421 (HDJS55009, Not Applicable); M1118179-496386 (HDJV61053, Not Applicable); M1118179-496386 (HDJV61054, Not Applicable); M1118179-526626 (GBWW60945, 010084068210392321GBWW6094611171207); M1118179-526626 (GBWW60946, 010084068210392321GBWW6094911171211); M1118179-526626 (GBWW60949, 010084068210389321PBWW6274611171120); M1118179-022806 (HDJM50505, Not Applicable); M1118179-022806 (HDJM50506, Not Applicable); M1118179-022806 (HDJM50507, Not Applicable); M1118179-022806 (HDJM50509, Not Applicable); M1118179-022806 (HDJM50510, Not Applicable); M1118179-022806 (HDJM50511, Not Applicable); M1118179-022806 (HDJM50512, Not Applicable); M1118179-022806 (HDJM50513, Not Applicable); M1118179-022806 (HDJM50514, Not Applicable); M1118179-022806 (HDJM50515, Not Applicable); M1118179-022806 (HDJM50517, Not Applicable); M1118179-022806 (HDJM50518, Not Applicable); M1118179-022806 (HDJM50519, Not Applicable); M1118179-022806 (HDJM51465, Not Applicable); M1118179-022806 (HDJM51466, Not Applicable); M1118179-026902 (HDJP51150, Not Applicable); M1118179-026902 (HDJP51151, Not Applicable); M1118179-026902 (HDJP51152, Not Applicable); M1118179-026902 (HDJP51153, Not Applicable); M1118179-026902 (HDJP51154, Not Applicable); M1118179-026902 (HDJP51155, Not Applicable); M1118179-026902 (HDJP51156, Not Applicable); M1118179-026902 (HDJP51157, Not Applicable); M1118179-026902 (HDJP51158, Not Applicable); M1118179-026902 (HDJP51159, Not Applicable); M1118179-026902 (HDJP51160, Not Applicable); M1118179-026902 (HDJP51161, Not Applicable); M1118179-026902 (HDJP51162, Not Applicable); M1118179-026902 (HDJP51163, Not Applicable); M1118179-026902 (HDJP51164, Not Applicable); M1118179-026902 (HDJP51165, Not Applicable); M1118179-026902 (HDJP51166, Not Applicable); M1118179-026902 (HDJP51167, Not Applicable); M1118179-026902 (HDJP51168, Not Applicable); M1118179-026902 (HDJP51169, Not Applicable); M1118179-026902 (HDJP51170, Not Applicable); M1118179-026902 (HDJP51171, Not Applicable); M1118179-026902 (HDJP51172, Not Applicable); M1118179-026902 (HDJP51173, Not Applicable); M1118179-026902 (HDJP51174, Not Applicable); M1118179-026902 (HDJP51175, Not Applicable); M1118179-026902 (HDJP51176, Not Applicable); M1118179-026902 (HDJP51177, Not Applicable); M1118179-026902 (HDJP51178, Not Applicable); M1118179-026902 (HDJP51179, Not Applicable); M1118179-026902 (HDJP51180, Not Applicable); M1118179-025076 (HDJU61647, Not Applicable); M1118179-025076 (HDJU61648, Not Applicable); M1118179-025076 (HDJU61649, Not Applicable); M1118179-026902 (HDJQ51123, Not Applicable); M1118179-026902 (HDJQ51124, Not Applicable); M1118179-026902 (HDJQ51125, Not Applicable); M1118179-026902 (HDJQ51126, Not Applicable); M1118179-026902 (HDJQ51127, Not Applicable); M1118179-024117 (HDJL50034, Not Applicable); M1118179-024117 (HDJL50184, Not Applicable); M1118179-024117 (HDJM50056, Not Applicable); M1118179-024117 (HDJM50178, Not Applicable); M1118179-024117 (HDJM50583, Not Applicable); M1118179-068136 (HDJQ50388, Not Applicable); M1118179-068136 (HDJQ50389, Not Applicable); M1118179-150421 (HDJM50094, Not Applicable); M1118179-527029 (GBWW60297, 010084068210392321GBWW6029711170501); M1118179-527029 (GBWW60517, 010084068210392321GBWW6051911170711); M1118179-527029 (GBWW60519, 010084068210392321GBWW6052011170711); M1118179-527029 (GBWW60520, 010084068210392321GBWW6052211170711); M1118179-527029 (GBWW60522, 010084068210392321GBWW6052311170711); M1118179-527029 (GBWW60523, 010084068210392321GBWW6052411170711); M1118179-527029 (GBWW60524, 010084068210392321GBWW6052611170711); M1118179-527029 (GBWW60526, 010084068210392321GBWW6064011170808); M1118179-527029 (GBWW60640, 010084068210392321GBWW6064111170808); M1118179-527029 (GBWW60641, 010084068210392321GBWW6064211170808); M1118179-527029 (GBWW60642, Not Applicable); M1118179-044239 (HDJP50858, Not Applicable); M1118179-044239 (HDJQ50818, Not Applicable); M1118179-044239 (HDJS50635, Not Applicable); M1118179-044239 (HDJS51324, Not Applicable); M1118179-029702 (HDJU60779, Not Applicable); M1118179-029702 (HDJU60780, Not Applicable); M1118179-499466 (GBWV60334, 010084068210392321GBWV6033411160919); M1118179-499466 (GBWV60335, 010084068210392321GBWV6033511160919); M1118179-115425 (HDJU61885, Not Applicable); M1118179-025076 (HDJU65944, Not Applicable); M1118179-044239 (HDJQ52271, Not Applicable); M1118179-044239 (HDJN52489, Not Applicable); M1118179-025076 (HDJT50319, Not Applicable); M1118179-044239 (HDJN52490, Not Applicable); M1118179-526477 (GBWX60136, 010084068210392321GBWX6013711180328); M1118179-526477 (GBWX60137, 010084068210392321GBWX7029011180823); M1118179-526477 (GBWX70290, 010084068210392321GBWX7029111180823); M1118179-526477 (GBWX70291, Not Applicable); M1118179-526477 (GBWX70443, Not Applicable); M1118179-026902 (HDJT60722, Not Applicable); M1118179-026902 (HDJT60723, Not Applicable); M1118179-026902 (HDJT60724, Not Applicable); M1118179-024446 (HDJU63305, Not Applicable); M1118179-024446 (HDJU63306, Not Applicable); M1118179-024446 (HDJU63307, Not Applicable); M1118179-502718 (GBWV60295, 010084068210392321GBWV6029511160902); M1118179-502718 (GBWV60296, 010084068210392321GBWV6029611160902); M1118179-020107 (HDJL50296, Not Applicable); M1118179-020107 (HDJL50297, Not Applicable); M1118179-020107 (HDJL50298, Not Applicable); M1118179-026713 (HDJN51958, Not Applicable); M1118179-026713 (HDJN51959, Not Applicable); M1118179-026713 (HDJP51288, Not Applicable); M1118179-026713 (HDJP51289, Not Applicable); M1118179-024011 (HDJP51287, Not Applicable); M1118179-527594 (GBWW60197, 010084068210392321GBWW6019711170315); M1118179-527594 (GBWW60198, 010084068210392321GBWW6019811170315); M1118179-527594 (GBWW60199, 010084068210392321GBWW6019911170315); M1118179-527594 (GBWX70100, 010084068210392321GBWX7010111180323); M1118179-527594 (GBWX70101, 010084068210392321GBWX7010211180323); M1118179-527594 (GBWX70102, 010084068210389321PBWX6033111180323); M1118179-023250 (HDJM50673, Not Applicable); M1118179-023250 (HDJM50674, Not Applicable); M1118179-024011 (HDJM51593, Not Applicable); M1118179-024011 (HDJM51594, Not Applicable); M1118179-024446 (HDJQ50732, Not Applicable); M1118179-024446 (HDJQ50742, Not Applicable); M1118179-024446 (HDJQ51526, Not Applicable); M1118179-029089 (HDJR54127, Not Applicable); M1118179-029089 (HDJR54128, Not Applicable); M1118179-029089 (HDJR54129, Not Applicable); M1118179-029089 (HDJR54130, Not Applicable); M1118179-029089 (HDJR54131, Not Applicable); M1118179-029089 (HDJR54132, Not Applicable); M1118179-029089 (HDJR56208, Not Applicable); M1118179-029089 (HDJR56209, Not Applicable); M1118179-029089 (HDJR56210, Not Applicable); M1118179-029089 (HDJR56211, Not Applicable); M1118179-029089 (HDJR56212, Not Applicable); M1118179-029089 (HDJR56213, Not Applicable); M1118179-029089 (HDJR56214, Not Applicable); M1118179-029089 (HDJR56215, Not Applicable); M1118179-029089 (HDJR56216, Not Applicable); M1118179-029089 (HDJR56217, Not Applicable); M1118179-023250 (HDJR57902, Not Applicable); M1118179-023250 (HDJR57903, Not Applicable); M1118179-023250 (HDJS51733, Not Applicable); M1118179-023250 (HDJS51734, Not Applicable); M1118179-029089 (HDJT60619, Not Applicable); M1118179-029089 (HDJT60620, Not Applicable); M1118179-029089 (HDJT60621, Not Applicable); M1118179-029089 (HDJU60899, Not Applicable); M1118179-029089 (HDJU60900, Not Applicable); M1118179-029089 (HDJT50063, Not Applicable); M1118179-029089 (HDJT50064, Not Applicable); M1118179-029089 (HDJT50065, Not Applicable); M1118179-029089 (HDJT50066, Not Applicable); M1118179-029089 (HDJT50067, Not Applicable); M1118179-029089 (HDJT50068, Not Applicable); M1118179-029089 (HDJT50069, Not Applicable); M1118179-029089 (HDJT50070, Not Applicable); M1118179-029089 (HDJT50071, Not Applicable); M1118179-029089 (HDJT50072, Not Applicable); M1118179-029089 (HDJT50073, Not Applicable); M1118179-029089 (HDJT50074, Not Applicable); M1118179-029089 (HDJT61073, Not Applicable); M1118179-029089 (HDJT61074, Not Applicable); M1118179-029089 (HDJT61075, Not Applicable); M1118179-029089 (HDJT61076, Not Applicable); M1118179-029089 (HDJT61077, Not Applicable); M1118179-029089 (HDJT61078, Not Applicable); M1118179-024201 (HDJP50311, Not Applicable); M1118179-535387 (GBWW60414, 010084068210392321GBWW6041411170531); M1118179-022861 (HDJQ51573, Not Applicable); M1118179-022861 (HDJR54164, Not Applicable); M1118179-022861 (HDJR54165, Not Applicable); M1118179-505279 (GBWV60100, 010084068210392321GBWV6010011160615); M1118179-261253 (HDJT51356, Not Applicable); M1118179-022861 (HDJM51848, Not Applicable); M1118179-023044 (HDJP52806, Not Applicable); M1118179-023044 (HDJP52807, Not Applicable); M1118179-022861 (HDJR50477, Not Applicable); M1118179-527594 (GBWX70266, 010084068210389321PBWX7143611180808); M1118179-527594 (GBWX70288, 010084068210389321PBWX7168911180905); M1118179-529113 (GBWW60322, 010084068210392321GBWW6032211170510); M1118179-529113 (GBWW60323, 010084068210392321GBWW6032311170510); M1118179-529113 (GBWW60429, 010084068210392321GBWW6040111170523); M1118179-024011 (HDJQ51961, Not Applicable); M1118179-024011 (HDJQ51962, Not Applicable); M1118179-024011 (HDJQ51963, Not Applicable); M1118179-024011 (HDJQ51966, Not Applicable); M1118179-020958 (HDJM50199, Not Applicable); M1118179-020958 (HDJM50200, Not Applicable); M1118179-020958 (HDJM50201, Not Applicable); M1118179-020841 (HDJM50142, Not Applicable); M1118179-023250 (HDJM50867, Not Applicable); M1118179-023250 (HDJM50868, Not Applicable); M1118179-023250 (HDJM50869, Not Applicable); M1118179-023250 (HDJM50870, Not Applicable); M1118179-023250 (HDJM50871, Not Applicable); M1118179-023250 (HDJM50872, Not Applicable); M1118179-529113 (GBWW60238, 010084068210392321GBWW6023811170327); M1118179-529113 (GBWW60239, 010084068210392321GBWW6023911170327); M1118179-526626 (GBWW60307, 010084068210392321GBWW6030711170509); M1118179-526626 (GBWW60352, 010084068210392321GBWW6035211170516); M1118179-526626 (GBWW60354, 010084068210392321GBWW6035411170516); M1118179-526626 (GBWW60355, 010084068210392321GBWW6035511170516); M1118179-526626 (GBWW60356, 010084068210392321GBWW6035611170516); M1118179-022677 (HDJM50436, Not Applicable); M1118179-022677 (HDJM50437, Not Applicable); M1118179-022677 (HDJM50438, Not Applicable); M1118179-023044 (HDJM51438, Not Applicable); M1118179-023044 (HDJM51439, Not Applicable); M1118179-023044 (HDJM51440, Not Applicable); M1118179-539102 (GBWW60549, 010084068210392321GBWW6055011170721); M1118179-539102 (GBWW60550, 010084068210392321GBWW6055111170721); M1118179-539102 (GBWW60551, 010084068210392321GBWW6055211170721); M1118179-539102 (GBWW60552, 010084068210392321GBWW6055311170721); M1118179-539102 (GBWW60553, 010084068210392321GBWW6055411170721); M1118179-539102 (GBWW60554, 010084068210392321GBWW6055511170721); M1118179-539102 (GBWW60555…
Recall started: March 15, 2019
Device type: Warmer, Infant Radiant
Root cause (FDA): Device Design
What the company told customers: GE Healthcare notified customers on about 03/15/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were instructed to 1) Inspect the warmer bedside panels latch areas and the areas connecting the panel to the bed for any cracks or damages per the addendum included in the mailing. If any portion of the bedside panels or latches are cracked or broken, stop use of the warmer. Complete and return the attached response form in via FAX TO: +1-410-630-5579, or scanning or taking a photo of the completed form e-mailing to: MIC.Recall@ge.com indicating what components require replacement. If the Warmer bedside panels or latches have no cracks or damage, continue to Safety Instruction 2. 2) If the Warmer bedside panels or latches have no cracks or damage, you may continue to use your warmer. Apply Safety labels included in the mailing to the warmer by following the below instructions: a) Clean area with a cleaning solution recommended in the Operation and Maintenance Manual. b)Wait for the area to dry. c)Peel off label 1 and apply it to the front (south) bedside panel at the location shown in the illustration. d)Peel off label 2 and apply it to the left (west) bedside panel at the location shown in the illustration. e)Peel off label 3 and apply it to the right (east) bedside panel at the location shown in the illustration. 3) Review the attached Addendum and place it with your Warmer Operation and Maintenance Manual. Customers were instructed that GE Healthcare will replace all cracked or damaged bedside panels/latches at not cost. Complete and return the attached "Customer Response" form via e-ail to MIC.Recall@ge.com and a GE Representative contact you to arrange for a replacement. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative. On about 06/14/2019, GE Healthcare issued a press release and sent customers an "AMENDED - URGENT MEDICAL DEVICE RECALL" letter.
Recall number: Z-1846-2019

Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates…

Product: 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.
Quantity: 28,094 units
Codes and lots: 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…
Recall started: March 15, 2019
Device type: Warmer, Infant Radiant
Root cause (FDA): Device Design
What the company told customers: GE Healthcare notified customers on about 03/15/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were instructed to 1) Inspect the warmer bedside panels latch areas and the areas connecting the panel to the bed for any cracks or damages per the addendum included in the mailing. If any portion of the bedside panels or latches are cracked or broken, stop use of the warmer. Complete and return the attached response form in via FAX TO: +1-410-630-5579, or scanning or taking a photo of the completed form e-mailing to: MIC.Recall@ge.com indicating what components require replacement. If the Warmer bedside panels or latches have no cracks or damage, continue to Safety Instruction 2. 2) If the Warmer bedside panels or latches have no cracks or damage, you may continue to use your warmer. Apply Safety labels included in the mailing to the warmer by following the below instructions: a) Clean area with a cleaning solution recommended in the Operation and Maintenance Manual. b)Wait for the area to dry. c)Peel off label 1 and apply it to the front (south) bedside panel at the location shown in the illustration. d)Peel off label 2 and apply it to the left (west) bedside panel at the location shown in the illustration. e)Peel off label 3 and apply it to the right (east) bedside panel at the location shown in the illustration. 3) Review the attached Addendum and place it with your Warmer Operation and Maintenance Manual. Customers were instructed that GE Healthcare will replace all cracked or damaged bedside panels/latches at not cost. Complete and return the attached "Customer Response" form via e-ail to MIC.Recall@ge.com and a GE Representative contact you to arrange for a replacement. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative. On about 06/14/2019, GE Healthcare issued a press release and sent customers an "AMENDED - URGENT MEDICAL DEVICE RECALL" letter.
Recall number: Z-1847-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1846-2019, Z-1847-2019. The agency record governs; check it and the company before acting.

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