Giraffe Incubator Carestation. Neonatal incubator. recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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);

Product

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

Recalling firm

GE Healthcare, LLC

Quantity

1,724 devices total

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.

Recall date

November 28, 2018

Classification

Class II

Status

Terminated

Agency

FDA (device)