—#167867

Product

Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1

FDA product code: FMZ — Incubator, Neonatal
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K152809
Affected lot / code info: 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);

Why it was recalled

Potential electric leakage affecting the user.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated: 2018-09-25
Terminated: 2020-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167867. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.