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FDA · Medical device recall

Giraffe OmniBed Carestation… and 5 more products

Nov. 28, 2018 Class II

Date
Nov. 28, 2018
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Terminated
Filed by
GE Healthcare, LLC
Reason
Potential electric leakage affecting the user.
Distribution pattern
Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

6 products in this recall

Giraffe OmniBed Carestation…

Product
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Quantity
1,724 devices total
Codes and lots
Model Number, UDI (Serial Number): 2082844-001-526493, 010084068211686221TABX6226911180201 (TABX62269); 2082844-001-526493, 010084068211686221TABX6215911180122 (TABX62159); 2082844-001-526493, 010084068211686221TABX6219811180129 (TABX62198); 2082844-001-526493, 010084068211686221TABX6227011180201 (TABX62270); 2082844-001-526493, 010084068211686221TABX6229111180202 (TABX62291); 2082844-001-526493, 010084068211686221TABX6215611180122 (TABX62156); 2082844-001-526493, 010084068211686221TABX6226011180201 (TABX62260); 2082844-001-526493, 010084068211686221TABX6213511180119 (TABX62135); 2082844-001-526493, 010084068211686221TABX6218911180124 (TABX62189); 2082844-001-526493, 010084068211686221TABX6219611180124 (TABX62196); 2082844-001-526493, 010084068211686221TABX6218811180124 (TABX62188); 2082844-001-526493, 010084068211686221TABX6216011180122 (TABX62160); 2082844-001-487119, To be provided (TABV60550); 2082844-001-526493, 010084068211686221TABW6398711171213 (TABW63987); 2082844-001-526493, 010084068211686221TABX6214111180119 (TABX62141); 2082844-001-526493, 010084068211686221TABW6409911171219 (TABW64099); 2082844-001-526493, 010084068211686221TABW6400911171213 (TABW64009); 2082844-001-526493, 010084068211686221TABW6396611171211 (TABW63966); 2082844-001-526493, 010084068211686221TABW6400811171213 (TABW64008); 2082844-001-526493, 010084068211686221TABX6215411180122 (TABX62154); 2082844-001-526493, 010084068211686221TABW6408611171219 (TABW64086); 2082844-001-526493, 010084068211686221TABX6210811180117 (TABX62108); 2082844-001-526493, 010084068211686221TABX6213011180119 (TABX62130); 2082844-001-526493, 010084068211686221TABW6406911171219 (TABW64069); 2082844-001-526493, 010084068211686221TABW6408411171219 (TABW64084); 2082844-001-526493, 010084068211686221TABW6404311171218 (TABW64043); 2082844-001-526493, 010084068211686221TABW6409811171219 (TABW64098); 2082844-001-526493, 010084068211686221TABW6396411171211 (TABW63964); 2082844-001-526493, 010084068211686221TABW6404911171218 (TABW64049); 2082844-001-526493, 010084068211686221TABW6395411171211 (TABW63954); 2082844-001-526493, 010084068211686221TABW6408711171219 (TABW64087); 2082844-001-487119, Not Applicable (TABV60078); 2082844-001-526493, 010084068211686221TABX6232011180207 (TABX62320); 2082844-001-526493, 010084068211686221TABX6227211180201 (TABX62272); 2082844-001-526493, 010084068211686221TABX6211811180119 (TABX62118); 2082844-001-526493, 010084068211686221TABX6214611180119 (TABX62146); 2082844-001-526493, 010084068211686221TABW6398311171213 (TABW63983); 2082844-001-526493, 010084068211686221TABW6399411171213 (TABW63994); 2082844-001-526493, 010084068211686221TABX6220011180129 (TABX62200); 2082844-001-526493, 010084068211686221TABW6396211171211 (TABW63962); 2082844-001-526493, 010084068211686221TABX6227611180201 (TABX62276); 2082844-001-487119, Not Applicable (TABV60092); 2082844-001-526493, 010084068211686221TABW6393811171211 (TABW63938); 2082844-001-526493, 010084068211686221TABW6399511171213 (TABW63995); 2082844-001-526493, 010084068211686221TABX6213111180119 (TABX62131); 2082844-001-526493, 010084068211686221TABX6225711180201 (TABX62257); 2082844-001-526493, 010084068211686221TABX6214011180119 (TABX62140); 2082844-001-526493, 010084068211686221TABX6226411180201 (TABX62264); 2082844-001-526493, 010084068211686221TABX6231911180207 (TABX62319); 2082844-001-526493, 010084068211686221TABX6230111180202 (TABX62301); 2082844-001-526493, 010084068211686221TABX6228711180202 (TABX62287); 2082844-001-526493, 010084068211686221TABX6229611180202 (TABX62296); 2082844-001-526493, 010084068211686221TABX6230011180202 (TABX62300); 2082844-001-526493, 010084068211686221TABX6233311180207 (TABX62333); 2082844-001-526493, 010084068211686221TABX6233111180207 (TABX62331); 2082844-001-526493, 010084068211686221TABX6229011180202 (TABX62290); 2082844-001-526493, 010084068211686221TABX6229311180202 (TABX62293); 2082844-001-526493, 010084068211686221TABX6216311180123 (TABX62163); 2082844-001-526493, 010084068211686221TABX6223511180130 (TABX62235); 2082844-001-526493, 010084068211686221TABX6222711180130 (TABX62227); 2082844-001-526493, 010084068211686221TABX6216811180123 (TABX62168); 2082844-001-526493, 010084068211686221TABX6216411180123 (TABX62164); 2082844-001-526493, 010084068211686221TABX6214911180122 (TABX62149); 2082844-001-526493, 010084068211686221TABX6217811180123 (TABX62178); 2082844-001-526493, 010084068211686221TABX6220611180129 (TABX62206); 2082844-001-526493, 010084068211686221TABX6216511180123 (TABX62165); 2082844-001-526493, 010084068211686221TABX6225011180201 (TABX62250); 2082844-001-526493, 010084068211686221TABX6217311180123 (TABX62173); 2082844-001-526493, 010084068211686221TABX6216211180123 (TABX62162); 2082844-001-526493, 010084068211686221TABX6216611180123 (TABX62166); 2082844-001-526493, 010084068211686221TABX6223411180130 (TABX62234); 2082844-001-526493, 010084068211686221TABX6220811180129 (TABX62208); 2082844-001-526493, 010084068211686221TABW6395211171211 (TABW63952); 2082844-001-526493, 010084068211686221TABW6395111171211 (TABW63951); 2082844-001-526493, 010084068211686221TABW6407811171219 (TABW64078); 2082844-001-526493, 010084068211686221TABX6211011180117 (TABX62110); 2082844-001-526493, 010084068211686221TABX6211311180117 (TABX62113); 2082844-001-526493, 010084068211686221TABX6233211180207 (TABX62332); 2082844-001-526493, 010084068211686221TABX6228211180201 (TABX62282); 2082844-001-526493, 010084068211686221TABX6228311180201 (TABX62283); 2082844-001-526493, 010084068211686221TABW6404611171218 (TABW64046); 2082844-001-526493, 010084068211686221TABW6400011171213 (TABW64000); 2082844-001-526493, 010084068211686221TABW6409511171219 (TABW64095); 2082844-001-526493, 010084068211686221TABW6409611171219 (TABW64096); 2082844-001-526493, 010084068211686221TABW6393311171211 (TABW63933); 2082844-001-526493, 010084068211686221TABX6232411180207 (TABX62324); 2082844-001-526493, 010084068211686221TABX6229211180202 (TABX62292); 2082844-001-526493, 010084068211686221TABX6225411180201 (TABX62254); 2082844-001-526493, 010084068211686221TABX6225511180201 (TABX62255); 2082844-001-526493, 010084068211686221TABX6225811180201 (TABX62258); 2082844-001-487119, Not Applicable (TABV60433); 2082844-001-526493, 010084068211686221TABX6219711180124 (TABX62197); 2082844-001-526493, 010084068211686221TABX6212811180119 (TABX62128); 2082844-001-526493, 010084068211686221TABW6394411171211 (TABW63944); 2082844-001-526493, 010084068211686221TABW6398211171213 (TABW63982); 2082844-001-526493, 010084068211686221TABW6394811171211 (TABW63948); 2082844-001-526493, 010084068211686221TABW6394011171211 (TABW63940); 2082844-001-526493, 010084068211686221TABX6222611180130 (TABX62226); 2082844-001-526493, 010084068211686221TABW6393711171211 (TABW63937); 2082844-001-526493, 010084068211686221TABX6224011180130 (TABX62240); 2082844-001-526493, 010084068211686221TABX6223911180130 (TABX62239); 2082844-001-526493, 010084068211686221TABW6399611171213 (TABW63996); 2082844-001-526493, 010084068211686221TABX6224311180130 (TABX62243); 2082844-001-526493, 010084068211686221TABX6224211180130 (TABX62242); 2082844-001-526493, 010084068211686221TABX6224411180201 (TABX62244); 2082844-001-526493, 010084068211686221TABX6222911180130 (TABX62229); 2082844-001-526769, 010084068211686221TABW6397711171212 (TABW63977); 2082844-001-526493, 010084068211686221TABW6401311171213 (TABW64013); 2082844-001-526493, 010084068211686221TABW6395911171211 (TABW63959); 2082844-001-526493, 010084068211686221TABW6408211171219 (TABW64082); 2082844-001-526493, 010084068211686221TABW6402311171213 (TABW64023); 2082844-001-526493, 010084068211686221TABW6396511171211 (TABW63965); 2082844-001-526493, 010084068211686221TABX6233511180207 (TABX62335); 2082844-001-526493, 010084068211686221TABX6229511180202 (TABX62295); 2082844-001-526493, 010084068211686221TABX6224611180201 (TABX62246); 2082844-001-526493, 010084068211686221TABX6225311180201 (TABX62253); 2082844-001-526493, 010084068211686221TABX6222311180130 (TABX62223); 2082844-001-526493, 010084068211686221TABX6225111180201 (TABX62251); 2082844-001-526493, 010084068211686221TABX6225211180201 (TABX62252); 2082844-001-526493, 010084068211686221TABX6223311180130 (TABX62233); 2082844-001-526493, 010084068211686221TABX6223211180130 (TABX62232); 2082844-001-526493, 010084068211686221TABX6223611180130 (TABX62236); 2082844-001-526493, 010084068211686221TABX6224811180201 (TABX62248); 2082844-001-526493, 010084068211686221TABX6223811180130 (TABX62238); 2082844-001-526493, 010084068211686221TABX6224911180201 (TABX62249); 2082844-001-526493, 010084068211686221TABX6224511180201 (TABX62245); 2082844-001-526493, 010084068211686221TABX6210911180117 (TABX62109); 2082844-001-526493, 010084068211686221TABX6219411180124 (TABX62194); 2082844-001-526493, 010084068211686221TABX6219311180124 (TABX62193); 2082844-001-526493, 010084068211686221TABX6213911180119 (TABX62139); 2082844-001-526493, 010084068211686221TABX6216111180122 (TABX62161); 2082844-001-526493, 010084068211686221TABX6213611180119 (TABX62136); 2082844-001-526493, 010084068211686221TABX6212011180119 (TABX62120); 2082844-001-526493, 010084068211686221TABX6215811180122 (TABX62158); 2082844-001-526493, 010084068211686221TABX6213211180119 (TABX62132); 2082844-001-526493, 010084068211686221TABX6217111180123 (TABX62171); 2082844-001-526493, 010084068211686221TABX6221811180130 (TABX62218); 2082844-001-526493, 010084068211686221TABW6405911171219 (TABW64059); 2082844-001-526493, 010084068211686221TABX6224711180201 (TABX62247); 2082844-001-526493, 010084068211686221TABX6223111180130 (TABX62231); 2082844-001-403566, Not Applicable (TABU67011); 2082844-001-499499, 010084068211686221TABW6259811170606 (TABW62598); 2082844-001-430326, Not Applicable (TABV60027); 2082844-001-430326, Not Applicable (TABV60030); 2082844-001-430326, Not Applicable (TABV60028); 2082844-001-430326, Not Applicable (TABU67004); 2082844-001-462725, Not Applicable (TABU67040); 2082844-001-462725, Not Applicable (TABU67039); 2082844-001-462725, Not Applicable (TABU67056); 2082844-001-462725, Not Applicable (TABU67041); 2082844-001-462725, Not Applicable (TABU67053); 2082844-001-462725, Not Applicable (TABU67045); 2082844-001-462725, Not Applicable (TABU67047); 2082844-001-462725, Not Applicable (TABU67050); 2082844-001-462725, Not Applicable (TABU67043); 2082844-001-460023, Not Applicable (TABU67014); 2082844-001-510290, 010084068211685521TABV61236160902 (TABV61236); 2082844-001-558377, 010084068211686221TABX6238011180219 (TABX62380); 2082844-001-534467, 010084068211686221TABX6330711180628 (TABX63307); 2082844-001-534467, 010084068211686221TABX6330611180628 (TABX63306); 2082844-001-534467, 010084068211686221TABX6331411180628 (TABX63314); 2082844-001-534467, 010084068211686221TABX6236011180213 (TABX62360); 2082844-001-534467, 010084068211686221TABX6331211180628 (TABX63312); 2082844-001-534467, 010084068211686221TABX6331111180628 (TABX63311); 2082844-001-534467, 010084068211686221TABX6330911180628 (TABX63309); 2082844-001-534467, 010084068211686221TABX6331511180628 (TABX63315); 2082844-001-501649, 010084068211686221TABX6330411180626 (TABX63304); 2082844-001-501649, 010084068211686221TABX6330311180626 (TABX63303); 2082844-001-501649, 010084068211686221TABX6330511180626 (TABX63305); 2082844-001-467192, Not Applicable (TABV60033); 2082844-001-495642, Not Applicable (TABV60053); 2082844-001-508846, 010084068211686221TABX6247711180301 (TABX62477); 2082844-001-508846, 010084068211686221TABX6247611180301 (TABX62476); 2082844-001-508846, 010084068211686221TABX6246211180228 (TABX62462); 2082844-001-508846, 010084068211686221TABX6246311180228 (TABX62463); 2082844-001-508846, 010084068211686221TABX6248411180305 (TABX62484); 2082844-001-508846, 010084068211686221TABX6248511180305 (TABX62485); 2082844-001-498552, 010084068211686221TABX6248911180305 (TABX62489); 2082844-001-498552, 010084068211686221TABX6248611180305 (TABX62486); 2082844-001-498552, 010084068211686221TABX6248711180305…
Recall started
Sept. 25, 2018
Device type
Incubator, Neonatal
Root cause (FDA)
Process design
What the company told customers
GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number
Z-0479-2019

Giraffe Incubator Carestation…

Product
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Quantity
1,724 devices total
Codes and lots
Model Number, UDI (Serial Number): 2082844-002-527348, 010084068211685521TAAW6317711171213 (TAAW63177); 2082844-002-527348, 010084068211685521TAAW6317911171213 (TAAW63179); 2082844-002-527348, 010084068211685521TAAW6318111171213 (TAAW63181); 2082844-002-527348, 010084068211685521TAAX6208911180129 (TAAX62089); 2082844-002-527348, 010084068211685521TAAX6208811180124 (TAAX62088); 2082844-002-527348, 010084068211685521TAAX6208211180124 (TAAX62082); 2082844-002-527348, 010084068211685521TAAW6318011171213 (TAAW63180); 2082844-002-527348, 010084068211685521TAAW6317811171213 (TAAW63178); 2082844-002-527348, 010084068211685521TAAW6320511171221 (TAAW63205); 2082844-002-527348, 010084068211685521TAAW6320611171222 (TAAW63206); 2082844-002-527555, 010084068211685521TAAW6317611171212 (TAAW63176); 2082844-002-527348, 010084068211685521TAAX6207811180124 (TAAX62078); 2082844-002-527348, 010084068211685521TAAX6207911180124 (TAAX62079); 2082844-002-527238, 010084068211685521TAAW6317411171212 (TAAW63174); 2082844-002-527555, 010084068211685521TAAW6318411171221 (TAAW63184); 2082844-002-527555, 010084068211685521TAAW6318311171221 (TAAW63183); 2082844-002-527238, 010084068211685521TAAX6205311180105 (TAAX62053); 2082844-002-527238, 010084068211685521TAAX6205411180105 (TAAX62054); 2082844-002-527348, 010084068211685521TAAW6314411171129 (TAAW63144); 2082844-002-527555, 010084068211685521TAAW6318611171221 (TAAW63186); 2082844-002-527348, 010084068211685521TAAW6320711171229 (TAAW63207); 2082844-002-432598, Not Applicable (TAAV60034); 2082844-002-432598, Not Applicable (TAAV60030); 2082844-002-432598, Not Applicable (TAAV60037); 2082844-002-432598, Not Applicable (TAAV60038); 2082844-002-432598, Not Applicable (TAAV60029); 2082844-002-432598, Not Applicable (TAAV60032); 2082844-002-510421, 010084068211685521TAAX6212711180216 (TAAX62127); 2082844-002-510421, 010084068211685521TAAX6212811180216 (TAAX62128); 2082844-002-510421, 010084068211685521TAAX6212511180216 (TAAX62125); 2082844-002-510421, 010084068211685521TAAX6212611180216 (TAAX62126); 2082844-002-432598, Not Applicable (TAAU67008); 2082844-002-462502, Not Applicable (TAAV60017); 2082844-002-462502, Not Applicable (TAAV60016); 2082844-002-462502, Not Applicable (TAAV60018); 2082844-002-510421, 010084068211685521TAAX6244311180629 (TAAX62443); 2082844-002-510421, 010084068211685521TAAX6244411180629 (TAAX62444); 2082844-002-495552, Not Applicable (TAAV60044); 2082844-002-522829, 010084068211685521TAAX6207511180122 (TAAX62075); 2082844-002-518655, 010084068211685521TAAV62229161201 (TAAV62229); 2082844-002-518655, 010084068211685521TAAX6245211180709 (TAAX62452); 2082844-002-518655, 010084068211685521TAAX6245111180709 (TAAX62451); 2082844-002-507367, 010084068211685521TAAX6244811180629 (TAAX62448); 2082844-002-507367, 010084068211685521TAAX6244711180629 (TAAX62447); 2082844-002-507367, 010084068211685521TAAX6244611180629 (TAAX62446); 2082844-002-523548, 010084068211685521TAAX62458180710 (TAAX62458); 2082844-002-485100, Not Applicable (TAAV60015); 2082844-002-557041, 010084068211685521TAAX62092180130 (TAAX62092); 2082844-002-513404, 010084068211685521TAAX6244911180702 (TAAX62449); 2082844-002-513404, 010084068211685521TAAX6245011180702 (TAAX62450); 2082844-002-531629, 010084068211685521TAAX6218011180309 (TAAX62180); 2082844-002-521888, 010084068211685521TAAX6217811180307 (TAAX62178); 2082844-002-521888, 010084068211685521TAAX6217911180307 (TAAX62179); 2082844-002-565600, 010084068211685521TAAX62345180605 (TAAX62345); 2082844-002-565600, 010084068211685521TAAX62346180605 (TAAX62346); 2082844-002-565600, 010084068211685521TAAX62347180605 (TAAX62347); 2082844-002-561822, 010084068211685521TAAX6244511180629 (TAAX62445); 2082844-002-499251, Not Applicable (TAAV60093); 2082844-002-485199, Not Applicable (TAAV60022); 2082844-002-487400, Not Applicable (TAAV60039); 2082844-002-485199, Not Applicable (TAAV60019); 2082844-002-432598, Not Applicable (TAAU67007); 2082844-002-513261, 010084068211685521TAAV62017161004 (TAAV62017); 2082844-002-504704, 010084068211685521TAAX6215711180227 (TAAX62157); 2082844-002-504704, 010084068211685521TAAX6216111180227 (TAAX62161); 2082844-002-504704, 010084068211685521TAAX6215611180227 (TAAX62156); 2082844-002-504704, 010084068211685521TAAX6215811180227 (TAAX62158); 2082844-002-504704, 010084068211685521TAAX6215911180227 (TAAX62159); 2082844-002-504704, 010084068211685521TAAX6216011180227 (TAAX62160); 2082844-002-504704, 010084068211685521TAAX6216211180227 (TAAX62162); 2082844-002-504704, 010084068211685521TAAX6215511180227 (TAAX62155); 2082844-002-504704, 010084068211685521TAAX6214711180221 (TAAX62147); 2082844-002-462282, Not Applicable (TAAU67014); 2082844-002-504704, 010084068211685521TAAV6207511161027 (TAAV62075); 2082844-002-495731, Not Applicable (TAAV60047); 2082844-002-488520, Not Applicable (TAAV60041); 2082844-002-463794, Not Applicable (TAAU67021); 2082844-002-487628, Not Applicable (TAAV60042); 2082844-002-463794, Not Applicable (TAAU67020); 2082844-002-534787, 010084068211685521TAAX6209611180205 (TAAX62096); 2082844-002-534787, 010084068211685521TAAX6209511180205 (TAAX62095); 2082844-002-558138, 010084068211685521TAAX6213411180216 (TAAX62134); 2082844-002-558138, 010084068211685521TAAX6213211180216 (TAAX62132); 2082844-002-516797, 010084068211685521TAAV6212211161114 (TAAV62122); 2082844-002-521646, 010084068211685521TAAX62183180313 (TAAX62183); 2082844-002-521646, 010084068211685521TAAX62185180313 (TAAX62185); 2082844-002-521646, 010084068211685521TAAX62184180313 (TAAX62184); 2082844-002-523361, 010084068211685521TAAX62434180625 (TAAX62434); 2082844-002-523361, 010084068211685521TAAX62433180625 (TAAX62433); 2082844-002-523361, 010084068211685521TAAX62421180625 (TAAX62421); 2082844-002-523361, 010084068211685521TAAX62423180625 (TAAX62423); 2082844-002-523584, 010084068211685521TAAX62456180709 (TAAX62456); 2082844-002-523361, 010084068211685521TAAX62428180625 (TAAX62428); 2082844-002-523361, 010084068211685521TAAX62426180625 (TAAX62426); 2082844-002-523361, 010084068211685521TAAX62427180625 (TAAX62427); 2082844-002-523361, 010084068211685521TAAX62430180625 (TAAX62430); 2082844-002-523361, 010084068211685521TAAX62424180625 (TAAX62424); 2082844-002-523361, 010084068211685521TAAX62420180625 (TAAX62420); 2082844-002-523361, 010084068211685521TAAX62432180625 (TAAX62432); 2082844-002-523361, 010084068211685521TAAX62419180625 (TAAX62419); 2082844-002-523361, 010084068211685521TAAX62431180625 (TAAX62431); 2082844-002-523361, 010084068211685521TAAX62425180625 (TAAX62425); 2082844-002-523361, 010084068211685521TAAX62422180625 (TAAX62422); 2082844-002-523361, 010084068211685521TAAX62409180625 (TAAX62409); 2082844-002-523361, 010084068211685521TAAX62429180625 (TAAX62429); 2082844-002-559200, 010084068211685521TAAX6217411180302 (TAAX62174); 2082844-002-559200, 010084068211685521TAAX6217711180302 (TAAX62177); 2082844-002-559200, 010084068211685521TAAX6217611180302 (TAAX62176); 2082844-002-559200, 010084068211685521TAAX6217511180302 (TAAX62175); 2082844-002-498284, Not Applicable (TAAV60062); 2082844-002-523941, 010084068211685521TAAX6211911180215 (TAAX62119); 2082844-002-523941, 010084068211685521TAAX6212011180215 (TAAX62120); 2082844-002-498284, 010084068211685521TAAX6213611180220 (TAAX62136); 2082844-002-498284, 010084068211685521TAAX6214111180220 (TAAX62141); 2082844-002-498284, 010084068211685521TAAX6214311180220 (TAAX62143); 2082844-002-498284, 010084068211685521TAAX6213811180220 (TAAX62138); 2082844-002-498284, 010084068211685521TAAX6214011180220 (TAAX62140); 2082844-002-498284, 010084068211685521TAAX6214411180220 (TAAX62144); 2082844-002-498284, 010084068211685521TAAX6213911180220 (TAAX62139); 2082844-002-498284, 010084068211685521TAAX6214511180220 (TAAX62145); 2082844-002-498284, 010084068211685521TAAX6214211180220 (TAAX62142); 2082844-002-498284, 010084068211685521TAAX6214611180220 (TAAX62146); 2082844-002-498284, 010084068211685521TAAX6213711180220 (TAAX62137); 2082844-002-432596, Not Applicable (TAAV60056); 2082844-002-432596, Not Applicable (TAAV60057); 2082844-002-432596, Not Applicable (TAAV60059); 2082844-002-430325, Not Applicable (TAAU67001); 2082844-002-430325, Not Applicable (TAAU67002); 2082844-002-430325, Not Applicable (TAAU67012); 2082844-002-432596, Not Applicable (TAAU67015); 2082844-002-432596, Not Applicable (TAAU67016); 2082844-002-432596, Not Applicable (TAAV60007); 2082844-002-432596, Not Applicable (TAAV60006); 2082844-002-432596, Not Applicable (TAAV60011); 2082844-002-432596, Not Applicable (TAAV60012); 2082844-002-432596, Not Applicable (TAAV60009);
Recall started
Sept. 25, 2018
Device type
Incubator, Neonatal
Root cause (FDA)
Process design
What the company told customers
GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number
Z-0480-2019

Giraffe Warmer…

Product
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Quantity
1,724 devices total
Codes and lots
Model Number, UDI (Serial Number): M1118179-018104, Not Applicable (HDJM50056); M1118179-018118, Not Applicable (HDJM50178); M1118179-024117, Not Applicable (HDJM50583); M1118179-018118, Not Applicable (HDJM50094); M1118179-022861, Not Applicable (HDJR54165); M1118179-020841, Not Applicable (HDJM50142); M1118179-024117, Not Applicable (HDJQ50967); M1118179-024117, Not Applicable (HDJQ50971); M1118179-024117, Not Applicable (HDJQ50973); M1118179-024117, Not Applicable (HDJQ50972); M1118179-024117, Not Applicable (HDJQ50974); M1118179-022643, Not Applicable (HDJM52091); M1118179-018104, Not Applicable (HDJM50060); M1118179-150421, Not Applicable (HDJT51438); M1118179-150421, Not Applicable (HDJT51439); M1118179-022643, Not Applicable (HDJM50696); M1118179-150421, Not Applicable (HDJT51652); M1118179-022643, Not Applicable (HDJQ50385); M1118179-161255, Not Applicable (HDJT60578); M1118179-161255, Not Applicable (HDJT60576); M1118179-161255, Not Applicable (HDJT60572); M1118179-161255, Not Applicable (HDJT60584); M1118179-161255, Not Applicable (HDJT60568); M1118179-026229, Not Applicable (HDJM51309); M1118179-022643, Not Applicable (HDJM50420); M1118179-022643, Not Applicable (HDJM50419); M1118179-022643, Not Applicable (HDJM50693); M1118179-022643, Not Applicable (HDJM51718); M1118179-026229, Not Applicable (HDJM51567); M1118179-226273, Not Applicable (HDJT51359); M1118179-022393, Not Applicable (HDJM50289); M1118179-022393, Not Applicable (HDJM50288); M1118179-022861, Not Applicable (HDJM50957); M1118179-022861, Not Applicable (HDJM50956); M1118179-160267, Not Applicable (HDJT61386); M1118179-526626, 010084068210392321GBWX7019911180619 (GBWX70199); M1118179-023046, Not Applicable (HDJP52075); M1118179-023046, Not Applicable (HDJM50955); M1118179-021393, Not Applicable (HDJM50046); M1118179-021393, Not Applicable (HDJM50527); M1118179-024117, Not Applicable (HDJM50584); M1118179-559396, 010084068210392321GBWX7007211180312 (GBWX70072); M1118179-023046, Not Applicable (HDJR50514); M1118179-023046, Not Applicable (HDJM50387); M1118179-023046, Not Applicable (HDJM50386); M1118179-150421, Not Applicable (HDJT50842); M1118179-150421, Not Applicable (HDJT61375); M1118179-025977, Not Applicable (HDJQ50585); M1118179-025977, Not Applicable (HDJQ50581); M1118179-527794, 010084068210392321GBWX7017111180523 (GBWX70171); M1118179-527794, 010084068210392321GBWX7017011180523 (GBWX70170); M1118179-022861, Not Applicable (HDJM50343); M1118179-022643, Not Applicable (HDJM50695); M1118179-161255, Not Applicable (HDJT51954); M1118179-174787, Not Applicable (HDJT51358); M1118179-174787, Not Applicable (HDJT51357); M1118179-019026, Not Applicable (HDJL50356); M1118179-022643, Not Applicable (HDJP52630); M1118179-024044, Not Applicable (HDJM50573); M1118179-024044, Not Applicable (HDJM50574); M1118179-024044, Not Applicable (HDJM50572); M1118179-526477, 010084068210392321GBWW6032811170511 (GBWW60328); M1118179-019593, Not Applicable (HDJL50433); M1118179-019593, Not Applicable (HDJL50434); M1118179-019593, Not Applicable (HDJL50435); M1118179-019593, Not Applicable (HDJL50432); M1118179-018104, Not Applicable (HDJM50059); M1118179-018114, Not Applicable (HDJM50097); M1118179-026007, Not Applicable (HDJM51296); M1118179-529707, 010084068210392321GBWX7023811180627 (GBWX70238); M1118179-529707, 010084068210392321GBWX7023911180627 (GBWX70239); M1118179-022643, Not Applicable (HDJM50694); M1118179-022643, Not Applicable (HDJN51744); M1118179-022861, Not Applicable (HDJM51320); M1118179-022861, Not Applicable (HDJM51321); M1118179-526477, 010084068210392321GBWX7024211180627 (GBWX70242); M1118179-526477, 010084068210392321GBWW6032711170511 (GBWW60327); M1118179-024117, Not Applicable (HDJN52275); M1118179-018118, Not Applicable (HDJM50188); M1118179-150421, Not Applicable (HDJT50988); M1118179-254785, Not Applicable (HDJT51864); M1118179-023046, Not Applicable (HDJM50536); M1118179-023046, Not Applicable (HDJM50537); M1118179-150421, Not Applicable (HDJT50843); M1118179-018118, Not Applicable (HDJM50045); M1118179-018118, Not Applicable (HDJM50186); M1118179-018114, Not Applicable (HDJM50005); M1118179-018114, Not Applicable (HDJM50006); M1118179-018114, Not Applicable (HDJM50007); M1118179-018104, Not Applicable (HDJM50061); M1118179-018104, Not Applicable (HDJM50055); M1118179-022643, Not Applicable (HDJM50698); M1118179-022643, Not Applicable (HDJM50697); M1118179-027451, Not Applicable (HDJM51565); M1118179-027451, Not Applicable (HDJM51564); M1118179-027451, Not Applicable (HDJM51566); M1118179-242231, Not Applicable (HDJT50732); M1118179-150421, Not Applicable (HDJT50839); M1118179-150421, Not Applicable (HDJT50702); M1118179-150421, Not Applicable (HDJT50722); M1118179-023046, Not Applicable (HDJN50207); M1118179-018118, Not Applicable (HDJM50179); M1118179-018104, Not Applicable (HDJM50058); M1118179-018118, Not Applicable (HDJM50062); M1118179-018118, Not Applicable (HDJM50093); M1118179-023046, Not Applicable (HDJM50654); M1118179-025977, Not Applicable (HDJM51225); M1118179-022125, Not Applicable (HDJM50470); M1118179-018118, Not Applicable (HDJM50187); M1118179-023046, Not Applicable (HDJM50388); M1118179-023046, Not Applicable (HDJM50538); M1118179-023046, Not Applicable (HDJP51904); M1118179-150421, Not Applicable (HDJT50989); M1118179-023046, Not Applicable (HDJM51553); M1118179-023046, Not Applicable (HDJM51554); M1118179-150421, Not Applicable (HDJT50838); M1118179-018104, Not Applicable (HDJM50057); M1118179-022256, Not Applicable (HDJM50180); M1118179-018114, Not Applicable (HDJL50487); M1118179-025977, Not Applicable (HDJM51217); M1118179-025977, Not Applicable (HDJM51219); M1118179-025977, Not Applicable (HDJM51224); M1118179-025977, Not Applicable (HDJM51220); M1118179-025977, Not Applicable (HDJM51216); M1118179-025977, Not Applicable (HDJM51221); M1118179-025977, Not Applicable (HDJM51218); M1118179-025977, Not Applicable (HDJM51223); M1118179-025977, Not Applicable (HDJM51222); M1118179-044164, Not Applicable (HDJR50298); M1118179-044164, Not Applicable (HDJR56108); M1118179-026395, Not Applicable (HDJM51460); M1118179-026395, Not Applicable (HDJM51461); M1118179-022439, Not Applicable (HDJM50237); M1118179-021533, Not Applicable (HDJM50147); M1118179-027863, Not Applicable (HDJM51724); M1118179-044164, Not Applicable (HDJR50297); M1118179-044164, Not Applicable (HDJR52094); M1118179-044164, Not Applicable (HDJR52095); M1118179-044164, Not Applicable (HDJR52096); M1118179-496293, 010084068210392321GBWW6030811170510 (GBWW60308); M1118179-072924, Not Applicable (HDJQ50843); M1118179-022807, Not Applicable (HDJM50309); M1118179-235294, Not Applicable (HDJT51537); M1118179-019903, Not Applicable (HDJL50330); M1118179-019903, Not Applicable (HDJL50329); M1118179-026183, Not Applicable (HDJM51322); M1118179-067995, Not Applicable (HDJQ50334); M1118179-067995, Not Applicable (HDJQ50333); M1118179-276837, Not Applicable (HDJT50987); M1118179-100772, Not Applicable (HDJR50394); M1118179-026877, Not Applicable (HDJM51456); M1118179-026788, Not Applicable (HDJM51462); M1118179-278167, Not Applicable (HDJT51000); M1118179-246044, Not Applicable (HDJT51230); M1118179-024645, Not Applicable (HDJM50753); M1118179-024645, Not Applicable (HDJM50754); M1118179-024645, Not Applicable (HDJM50755); M1118179-023078, Not Applicable (HDJM50305); M1118179-023078, Not Applicable (HDJM50661); M1118179-023078, Not Applicable (HDJM50660); M1118179-024264, Not Applicable (HDJM50663); M1118179-024264, Not Applicable (HDJM50662); M1118179-023361, Not Applicable (HDJM50385); M1118179-025604, Not Applicable (HDJM51050); M1118179-044906, Not Applicable (HDJR50453); M1118179-022468, Not Applicable (HDJM50503); M1118179-186200, Not Applicable (HDJT50777); M1118179-186200, Not Applicable (HDJT50781); M1118179-160971, Not Applicable (HDJT50664); M1118179-160971, Not Applicable (HDJT51008); M1118179-022439, Not Applicable (HDJM50236); M1118179-343873, Not Applicable (HDJT61094); M1118179-024668, Not Applicable (HDJM50689); M1118179-525532, 010084068210392321GBWW6032011170510 (GBWW60320); M1118179-525532, 010084068210392321GBWW6033011170515 (GBWW60330); M1118179-525532, 010084068210392321GBWW6033111170515 (GBWW60331); M1118179-158967, Not Applicable (HDJT51411); M1118179-024625, Not Applicable (HDJM50688); M1118179-063038, Not Applicable (HDJQ50701); M1118179-052375, Not Applicable (HDJQ50342); M1118179-052375, Not Applicable (HDJQ51188); M1118179-066171, Not Applicable (HDJQ50128); M1118179-066171, Not Applicable (HDJQ50126); M1118179-285625, Not Applicable (HDJT51152); M1118179-030272, Not Applicable (HDJQ50874); M1118179-030272, Not Applicable (HDJQ50875); M1118179-025788, Not Applicable (HDJM51192); M1118179-024130, Not Applicable (HDJM50752); M1118179-024130, Not Applicable (HDJM51505); M1118179-024130, Not Applicable (HDJM50585); M1118179-028157, Not Applicable (HDJM51755); M1118179-025086, Not Applicable (HDJM50888); M1118179-022828, Not Applicable (HDJM50306); M1118179-181417, Not Applicable (HDJT50497); M1118179-052773, Not Applicable (HDJQ51128); M1118179-157969, Not Applicable (HDJT61086); M1118179-021221, Not Applicable (HDJM50000); M1118179-300415, Not Applicable (HDJT51840); M1118179-021221, Not Applicable (HDJM50001); M1118179-021221, Not Applicable (HDJM50002); M1118179-023156, Not Applicable (HDJM50655); M1118179-021576, Not Applicable (HDJM50043); M1118179-021576, Not Applicable (HDJM50044); M1118179-030504, Not Applicable (HDJN50129); M1118179-030504, Not Applicable (HDJN50126); M1118179-023145, Not Applicable (HDJM50323); M1118179-023156, Not Applicable (HDJM50336); M1118179-533902, 010084068210392321GBWW60349170515 (GBWW60349);
Recall started
Sept. 25, 2018
Device type
Warmer, Infant Radiant
Root cause (FDA)
Process design
What the company told customers
GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number
Z-0481-2019

Panda iRes Infant Radiant Warmer…

Product
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
Quantity
1,724 devices total
Codes and lots
Model Number, UDI (Serial Number): M1112198-526395, 010084068210389321PBWX7040911180413 (PBWX70409); M1112198-164657, Not Applicable (HDJT50683); M1112198-018125, Not Applicable (HDJM50048); M1112198-023789, Not Applicable (HDJM50529); M1112198-023787, Not Applicable (HDJM50528); M1112198-027124, Not Applicable (HDJP50065); M1112198-018125, Not Applicable (HDJM50047); M1112198-022592, Not Applicable (HDJM50596); M1112198-023488, Not Applicable (HDJQ50744); M1112198-024139, Not Applicable (HDJQ50819); M1112198-023359, Not Applicable (HDJR50385); M1112198-023359, Not Applicable (HDJR50389); M1112198-023359, Not Applicable (HDJR50382); M1112198-171607, Not Applicable (HDJS50605); M1112198-023391, Not Applicable (HDJM50439); M1112198-052019, Not Applicable (HDJR50487); M1112198-018105, Not Applicable (HDJM50140); M1112198-018105, Not Applicable (HDJM50139); M1112198-019900, Not Applicable (HDJM50471); M1112198-018105, Not Applicable (HDJM50138); M1112198-527790, 010084068210389321PBWX7065611180521 (PBWX70656); M1112198-164657, Not Applicable (HDJT51749); M1112198-022124, Not Applicable (HDJM50440); M1112198-018102, Not Applicable (HDJM50183); M1112198-023608, Not Applicable (HDJQ50986); M1112198-023608, Not Applicable (HDJQ50988); M1112198-023608, Not Applicable (HDJQ50992); M1112198-023608, Not Applicable (HDJQ50993); M1112198-023608, Not Applicable (HDJQ50994); M1112198-023608, Not Applicable (HDJQ50996); M1112198-023608, Not Applicable (HDJQ50998); M1112198-023608, Not Applicable (HDJQ50999); M1112198-023608, Not Applicable (HDJQ51000); M1112198-023608, Not Applicable (HDJQ50991); M1112198-526395, 010084068210389321PBWX7050111180501 (PBWX70501); M1112198-526773, 010084068210389321PBWW6086211170410 (PBWW60862); M1112198-024139, Not Applicable (HDJM50629); M1112198-024139, Not Applicable (HDJM50628); M1112198-164256, Not Applicable (HDJT51641); M1112198-184659, Not Applicable (HDJT60033); M1112198-022592, Not Applicable (HDJM51338); M1112198-022592, Not Applicable (HDJM51337); M1112198-164657, Not Applicable (HDJT61440); M1112198-164657, Not Applicable (HDJT61452); M1112198-023848, Not Applicable (HDJQ52172); M1112198-164256, Not Applicable (HDJT50739); M1112198-018697, Not Applicable (HDJM50290); M1112198-018697, Not Applicable (HDJM50291); M1112198-024139, Not Applicable (HDJP52571); M1112198-023488, Not Applicable (HDJM51404); M1112198-023488, Not Applicable (HDJM51607); M1112198-026336, Not Applicable (HDJM51242); M1112198-022697, Not Applicable (HDJN50090); M1112198-022822, Not Applicable (HDJM50492); M1112198-022822, Not Applicable (HDJM50493); M1112198-022822, Not Applicable (HDJM50495); M1112198-022822, Not Applicable (HDJM50494); M1112198-497258, 010084068210389321PBWV6064511160725 (PBWV60645); M1112198-164256, Not Applicable (HDJT50740); M1112198-023848, Not Applicable (HDJM50541); M1112198-023848, Not Applicable (HDJM50540); M1112198-023849, Not Applicable (HDJM50539); M1112198-022592, Not Applicable (HDJM50602); M1112198-022592, Not Applicable (HDJM50853); M1112198-022592, Not Applicable (HDJM50618); M1112198-022592, Not Applicable (HDJM50604); M1112198-022592, Not Applicable (HDJM50594); M1112198-022592, Not Applicable (HDJM50851); M1112198-022592, Not Applicable (HDJM50852); M1112198-022592, Not Applicable (HDJM50849); M1112198-022592, Not Applicable (HDJM50603); M1112198-022592, Not Applicable (HDJM50601); M1112198-022592, Not Applicable (HDJM50587); M1112198-022592, Not Applicable (HDJM50635); M1112198-022592, Not Applicable (HDJM50610); M1112198-022592, Not Applicable (HDJM50843); M1112198-022592, Not Applicable (HDJM50856); M1112198-019213, Not Applicable (HDJL50321); M1112198-019213, Not Applicable (HDJL50320); M1112198-019213, Not Applicable (HDJL50322); M1112198-019213, Not Applicable (HDJL50323); M1112198-024139, Not Applicable (HDJQ50738); M1112198-526773, 010084068210389321PBWX7019811180306 (PBWX70198); M1112198-526773, 010084068210389321PBWX7021611180308 (PBWX70216); M1112198-526773, 010084068210389321PBWX7073611180531 (PBWX70736); M1112198-526773, 010084068210389321PBWX7073811180601 (PBWX70738); M1112198-526773, 010084068210389321PBWX7074911180603 (PBWX70749); M1112198-175579, Not Applicable (HDJT51602); M1112198-023848, Not Applicable (HDJM50700); M1112198-025718, Not Applicable (HDJM51237); M1112198-024139, Not Applicable (HDJM50703); M1112198-024139, Not Applicable (HDJM50702); M1112198-022592, Not Applicable (HDJM50634); M1112198-022592, Not Applicable (HDJM51766); M1112198-023608, Not Applicable (HDJM50497); M1112198-023608, Not Applicable (HDJM50499); M1112198-022592, Not Applicable (HDJM51768); M1112198-022592, Not Applicable (HDJM51767); M1112198-022592, Not Applicable (HDJM51770); M1112198-022592, Not Applicable (HDJM51771); M1112198-023608, Not Applicable (HDJM50500); M1112198-023608, Not Applicable (HDJM50498); M1112198-023608, Not Applicable (HDJM50501); M1112198-023608, Not Applicable (HDJM50502); M1112198-022592, Not Applicable (HDJM50855); M1112198-018125, Not Applicable (HDJL50327); M1112198-022592, Not Applicable (HDJQ50074); M1112198-022592, Not Applicable (HDJQ50069); M1112198-022592, Not Applicable (HDJQ50071); M1112198-179805, Not Applicable (HDJU66024); M1112198-023848, Not Applicable (HDJQ50658); M1112198-023848, Not Applicable (HDJR50416); M1112198-526395, 010084068210389321PBWX7051411180502 (PBWX70514); M1112198-526395, 010084068210389321PBWX7087711180617 (PBWX70877); M1112198-024139, Not Applicable (HDJQ50367); M1112198-165361, Not Applicable (HDJT61403); M1112198-165361, Not Applicable (HDJT61404); M1112198-024139, Not Applicable (HDJM51922); M1112198-526773, 010084068210389321PBWW6086611170410 (PBWW60866); M1112198-526773, 010084068210389321PBWW6086311170410 (PBWW60863); M1112198-022070, Not Applicable (HDJM50181); M1112198-022592, Not Applicable (HDJM50611); M1112198-022592, Not Applicable (HDJM50854); M1112198-022592, Not Applicable (HDJM50847); M1112198-022592, Not Applicable (HDJM50842); M1112198-022592, Not Applicable (HDJM50595); M1112198-022592, Not Applicable (HDJM50590); M1112198-022592, Not Applicable (HDJM50591); M1112198-022592, Not Applicable (HDJM50657); M1112198-022592, Not Applicable (HDJM50636); M1112198-022592, Not Applicable (HDJM50848); M1112198-022592, Not Applicable (HDJM50844); M1112198-022592, Not Applicable (HDJM50837); M1112198-022592, Not Applicable (HDJM50608); M1112198-022592, Not Applicable (HDJM50600); M1112198-022592, Not Applicable (HDJM50593); M1112198-022592, Not Applicable (HDJM50597); M1112198-022592, Not Applicable (HDJM50586); M1112198-022592, Not Applicable (HDJM50846); M1112198-022592, Not Applicable (HDJM50839); M1112198-022592, Not Applicable (HDJM50836); M1112198-022592, Not Applicable (HDJM50588); M1112198-022592, Not Applicable (HDJM50614); M1112198-022592, Not Applicable (HDJM50613); M1112198-022592, Not Applicable (HDJM50589); M1112198-022592, Not Applicable (HDJM50612); M1112198-022592, Not Applicable (HDJM50658); M1112198-022592, Not Applicable (HDJM50642); M1112198-022592, Not Applicable (HDJM50643); M1112198-022592, Not Applicable (HDJM50841); M1112198-022592, Not Applicable (HDJM50489); M1112198-022592, Not Applicable (HDJM50617); M1112198-022592, Not Applicable (HDJM50641); M1112198-022592, Not Applicable (HDJM50656); M1112198-526395, 010084068210389321PBWX7057011180510 (PBWX70570); M1112198-526395, 010084068210389321PBWX7057511180510 (PBWX70575); M1112198-526395, 010084068210389321PBWX7064411180518 (PBWX70644); M1112198-526395, 010084068210389321PBWX7063611180517 (PBWX70636); M1112198-164657, Not Applicable (HDJT60402); M1112198-164657, Not Applicable (HDJT60407); M1112198-024139, Not Applicable (HDJM51179); M1112198-024139, Not Applicable (HDJM51180); M1112198-526773, 010084068210389321PBWW6123611170515 (PBWW61236); M1112198-164657, Not Applicable (HDJT51040); M1112198-164256, Not Applicable (HDJT60431); M1112198-164256, Not Applicable (HDJT60450); M1112198-175579, Not Applicable (HDJT50476); M1112198-526395, 010084068210389321PBWX6058411180601 (PBWX60584); M1112198-175579, Not Applicable (HDJT50620); M1112198-175579, Not Applicable (HDJT51433); M1112198-175579, Not Applicable (HDJT51432); M1112198-175579, Not Applicable (HDJT50622); M1112198-023848, Not Applicable (HDJM50699); M1112198-022592, Not Applicable (HDJM50605); M1112198-022592, Not Applicable (HDJM50609); M1112198-022592, Not Applicable (HDJM50616); M1112198-022592, Not Applicable (HDJM50598); M1112198-022592, Not Applicable (HDJM50592); M1112198-022592, Not Applicable (HDJM50599); M1112198-022592, Not Applicable (HDJM50644); M1112198-022592, Not Applicable (HDJM50640); M1112198-022592, Not Applicable (HDJM50607); M1112198-022592, Not Applicable (HDJM50639); M1112198-022592, Not Applicable (HDJM50606); M1112198-025718, Not Applicable (HDJM51454); M1112198-025718, Not Applicable (HDJM51455); M1112198-022697, Not Applicable (HDJM50300); M1112198-022697, Not Applicable (HDJM50297); M1112198-022697, Not Applicable (HDJM50295); M1112198-022697, Not Applicable (HDJM50301); M1112198-022697, Not Applicable (HDJM50299); M1112198-022697, Not Applicable (HDJM50298); M1112198-022697, Not Applicable (HDJM50293); M1112198-022697, Not Applicable (HDJM50296); M1112198-022697, Not Applicable (HDJM50294); M1112198-526773, 010084068210389321PBWW6086411170410 (PBWW60864); M1112198-023359, Not Applicable (HDJM50415); M1112198-023359, Not Applicable (HDJM50416); M1112198-023359, Not Applicable (HDJM50418); M1112198-023359, Not Applicable (HDJM50417); M1112198-025987, Not Applicable (HDJN50470); M1112198-018505, Not Applicable (HDJM50039); M1112198-018505, Not Applicable (HDJM50031); M1112198-018505, Not Applicable (HDJM50038); M1112198-018505, Not Applicable (HDJM50042); M1112198-018505, Not Applicable (HDJM50030); M1112198-018505, Not Applicable (HDJM50040); M1112198-018505, Not Applicable (HDJM50041); M1112198-018505, Not Applicable (HDJM50033); M1112198-018505, Not Applicable (HDJM50032); M1112198-018505, Not Applicable (HDJM50034); M1112198-018505, Not Applicable (HDJM50035); M1112198-018505, Not Applicable (HDJM50037); M1112198-018505, Not Applicable (HDJM50036); M1112198-025849, Not Applicable (HDJQ50490); M1112198-527554, 010084068210389321PBWX7000611180104 (PBWX70006); M1112198-164256, Not Applicable (HDJT60421); M1112198-164256, Not Applicable (HDJT51859); M1112198-165121, Not Applicable (HDJT60292); M1112198-165121, Not Applicable (HDJT60827); M1112198-195382, Not Applicable (HDJT51837); M1112198-018125, Not Applicable (HDJM50100); M1112198-024139, Not Applicable (HDJM50778); M1112198-024139, Not Applicable (HDJM50776); M1112198-024139, Not Applicable (HDJM50787); M1112198-526395, 010084068210389321PBWX7006911180202 (PBWX70069); M1112198-526395, 010084068210389321PBWX7007211180205 (PBWX70072); M1112198-025336, Not Applicable (HDJM50968); M1112198-157601, Not Applicable (HDJT51512); M1112198-526395, 010084068210389321PBWW6125011170516 (PBWW61250); M1112198-526395, 010084068210389321PBWW6124911170516 (PBWW61249); M1112198-023488, Not Applicable (HDJM50477); M1112198-018116, Not Applicable (HDJM50280); M1112198-018116, Not Applicable (HDJM50278); M1112198-018116, Not Applicable (HDJM50279); M1112198-027124, Not Applicable (HDJQ50478); M1112198-305577, Not Applicable (HDJT51784); M1112198-176923, Not Applicable (HDJT51790); M1112198-305577, Not Applicable (HDJT51781); M1112198-305577, Not Applicable (HDJT51785); M1112198-305577, Not Applicable (HDJT51786); M1112198-176923, Not Applicable (HDJT51791); M1112198-305577, Not Applicable (HDJT51782); M1112198-305577, Not Applicable (HDJT51787); M1112198-184659, Not Applicable (HDJT51866); M1112198-184659, Not Applicable (HDJT51913); M1112198-184659, Not Applicable (HDJT60043); M1112198-528031, 010084068210389321PBWX7070111180529 (PBWX70701); M1112198-528031, 010084068210389321PBWX7070611180530 (PBWX70706); M1112198-528031, 010084068210389321PBWX7070911180530 (PBWX70709); M1112198-528031, 010084068210389321PBWX7071411180530 (PBWX70714); M1112198-023848, Not Applicable…
Recall started
Sept. 25, 2018
Device type
Warmer, Infant Radiant
Root cause (FDA)
Process design
What the company told customers
GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number
Z-0482-2019

Panda Freestanding Warmer…

Product
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
Quantity
1,724 devices total
Codes and lots
Model Number, UDI (Serial Number): 2063568-001-535551, 010084068210391621PFSX7006711180626 (PFSX70067); 2063568-001-289325, Not Applicable (HDJT51400); 2063568-001-289325, Not Applicable (HDJT51401); 2063568-001-528373, 010084068210391621PFSX7005911180618 (PFSX70059); 2063568-001-529111, 010084068210391621PFSX7008111180731 (PFSX70081); 2063568-001-501555, 010084068210391621PFSV6011411161219 (PFSV60114); 2063568-001-562946, 010084068210391621PFSX7005011180503 (PFSX70050); 2063568-001-297793, Not Applicable (HDJT51542); 2063568-001-533799, 010084068210391621PFSW60069170515 (PFSW60069); 2063568-001-347865, Not Applicable (HDJT61189); 2063568-001-533888, 010084068210391621PFSW6007111170515 (PFSW60071); 2063568-001-533888, 010084068210391621PFSW6007011170515 (PFSW60070); 2063568-001-533888, 010084068210391621PFSW6007211170515 (PFSW60072);
Recall started
Sept. 25, 2018
Device type
Warmer, Infant Radiant
Root cause (FDA)
Process design
What the company told customers
GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number
Z-0483-2019

Panda Wall Mount warmer…

Product
Panda Wall Mount warmer. Infant radiant warmer
Quantity
1,724 devices total
Codes and lots
Model Number, UDI (Serial Number): 2063570-001-149242, Not Applicable (HDJU65781);
Recall started
Sept. 25, 2018
Device type
Warmer, Infant Radiant
Root cause (FDA)
Process design
What the company told customers
GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number
Z-0484-2019

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0479-2019, Z-0480-2019, Z-0481-2019, Z-0482-2019, Z-0483-2019, Z-0484-2019. The agency record governs; check it and the company before acting.

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