| | Class 2 Device Recall Incubator, Neonatal |  |
| Date Initiated by Firm | September 25, 2018 |
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| Create Date | November 19, 2018 |
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| Recall Status1 |
Terminated 3 on July 13, 2020 |
| Recall Number | Z-0480-2019 |
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| Recall Event ID |
81224 |
| 510(K)Number | K152809 |
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| Product Classification |
Incubator, neonatal - Product Code FMZ
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| Product | Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1 |
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| Code Information |
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); |
Recalling Firm/
Manufacturer |
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
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| For Additional Information Contact |
800-437-1171 |
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Manufacturer Reason
for Recall | Potential electric leakage affecting the user. |
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FDA Determined
Cause 2 | Process design |
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| Action | 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. |
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| Quantity in Commerce | 1,724 devices total |
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| Distribution | 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = FMZ
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