Device product
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Z-0480-2019
Product summary
- Event
- Event 81224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,724 devices total
- Official record key
device-enforcement:Z-0480-2019
Official wording
Reason: Potential electric leakage affecting the user.
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);
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.
Derived failure modes
-
Unknown
Potential electric leakage affecting the user.