DATEX--OHMEDA, INC.: GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer

Recall number

Z-0141-2025

Recalling firm

DATEX--OHMEDA, INC.

Product

GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer

Status

Completed

Initiated

2023-06-06

Posted

2024-10-31

Terminated

not on file

Reason

Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

Root cause

Component design/selection

Action

GE HealthCare notified its consignees of the issue by letter beginning on 06/06/2023 using a traceable means. The notice explained the issue of potentially higher levels of formaldehyde which rapidly decrease of a week, and instructions on how to accelerate the rate of dissipation if the unit had not yet been put into clinical use. For questions: contact 1-800-437-1171 or your local GE HealthCare Representative

Quantity

224 units

Distribution

worldwide

Lot, serial or model codes

1) 2082844-002-01040417, UDI: (01)00840682116855(21)TAAC70003(11)230106, (01)00840682116855(21)TAAC70004(11)230109, (01)00840682116855(21)TAAC70011(11)230110, (01)00840682116855(21)TAAC70012(11)230110, (01)00840682116855(21)TAAC70013(11)230111, (01)00840682116855(21)TAAC70015(11)230112, (01)00840682116855(21)TAAC70016(11)230112, (01)00840682116855(21)TAAC70020(11)230112, (01)00840682116855(21)TAAC70022(11)230112, (01)00840682116855(21)TAAC70024(11)230112, (01)00840682116855(21)TAAC70147(11)230317, (01)00840682116855(21)TAAC70148(11)230317, (01)00840682116855(21)TAAC70149(11)230317, (01)00840682116855(21)TAAC70150(11)230317, (01)00840682116855(21)TAAC70152(11)230320, (01)00840682116855(21)TAAC70153(11)230320, (01)00840682116855(21)TAAC70155(11)230322, (01)00840682116855(21)TAAC70158(11)230322, (01)00840682116855(21)TAAC70159(11)230323, (01)00840682116855(21)TAAC70160(11)230323, (01)00840682116855(21)TAAC70161(11)230323, (01)00840682116855(21)TAAC70162(11)230323, (01)00840682116855(21)TAAC70163(11)230324, (01)00840682116855(21)TAAC70164(11)230324, (01)00840682116855(21)TAAC70165(11)230324, (01)00840682116855(21)TAAC70166(11)230324, (01)00840682116855(21)TAAC70167(11)230327, (01)00840682116855(21)TAAC70169(11)230327, (01)00840682116855(21)TAAC70170(11)230327, (01)00840682116855(21)TAAC70171(11)230328, (01)00840682116855(21)TAAC70177(11)230330, (01)00840682116855(21)TAAC70178(11)230330, (01)00840682116855(21)TAAC70179(11)230331, (01)00840682116855(21)TAAC70181(11)230331, (01)00840682116855(21)TAAC70182(11)230331, (01)00840682116855(21)TAAC70184(11)230331, (01)00840682116855(21)TAAC70192(11)230405, (01)00840682116855(21)TAAC70193(11)230405, (01)00840682116855(21)TAAC70196(11)230405, (01)00840682116855(21)TAAC70197(11)230405, (01)00840682116855(21)TAAC70200(11)230407, (01)00840682116855(21)TAAC70201(11)230407, (01)00840682116855(21)TAAC70202(11)230407, (01)00840682116855(21)TAAC70203(11)230407, (01)00840682116855(21)TAAC70204(11)230407, (01)00840682116855(21)TAAC70205(11)230407, (01)00840682116855(21)TAAC70208(11)230411, (01)00840682116855(21)TAAC70209(11)230411, (01)00840682116855(21)TAAC70210(11)230411, (01)00840682116855(21)TAAC70211(11)230414, (01)00840682116855(21)TAAC70212(11)230414, (01)00840682116855(21)TAAC70213(11)230414, (01)00840682116855(21)TAAC70214(11)230414, (01)00840682116855(21)TAAC70215(11)230417, (01)00840682116855(21)TAAC70216(11)230417, (01)00840682116855(21)TAAC70217(11)230417, (01)00840682116855(21)TAAC70218(11)230417, (01)00840682116855(21)TAAC70223(11)230418, (01)00840682116855(21)TAAC70224(11)230418, (01)00840682116855(21)TAAC70225(11)230418, (01)00840682116855(21)TAAC70226(11)230418, (01)00840682116855(21)TAAC70227(11)230418, (01)00840682116855(21)TAAC70228(11)230418, (01)00840682116855(21)TAAC70229(11)230419, (01)00840682116855(21)TAAC70242(11)230421, (01)00840682116855(21)TAAC70243(11)230421, (01)00840682116855(21)TAAC70244(11)230421, (01)00840682116855(21)TAAC70245(11)230421, (01)00840682116855(21)TAAC70246(11)230421, (01)00840682116855(21)TAAC70247(11)230421; 2) 2082844-002-01044956, UDI: (01)008406821168552(21)TAA23140007SA(11)230404, (01)008406821168552(21)TAA23140008SA(11)230404; 3) 2082844-002-01058424, UDI: (01)00840682116855(21)TAAC70142(11)230213; 4) 2082844-002-01069017, UDI: (01)008406821168552(21)TAA23110001SA(11)230316, (01)008406821168552(21)TAA23110002SA(11)230316, (01)008406821168552(21)TAA23110003SA(11)230316; 5) 2082844-002-01089666, UDI: (01)00840682116855(21)TAAC70124(11)230201; 6) 2082844-002-01090474, UDI: (01)00840682116855(21)TAAC70126(11)230201, (01)00840682116855(21)TAAC70128(11)230206, (01)00840682116862(21)TAAC70132(11)230206, (01)00840682116855(21)TAAC70133(11)230206, (01)00840682116855(21)TAAC70125(11)230201, (01)00840682116855(21)TAAC70127(11)230206, (01)00840682116855(21)TAAC70129(11)230206, (01)00840682116855(21)TAAC70131(11)230206, (01)00840682116855(21)TAAC70136(11)230206, (01)00840682116855(21)TAAC70137(11)230206; 7) 2082844-002-01091269, UDI: (01)008406821168552(21)TAA23090001SA(11)230228 228; 8) 2082844-002-01093489, UDI: (01)00840682116855(21)TAAC70187(11)230403, (01)00840682116855(21)TAAC70188(11)230403, (01)00840682116855(21)TAAC70189(11)230403, (01)00840682116855(21)TAAC70190(11)230403, (01)00840682116855(21)TAAC70191(11)230403; 9) 2082844-002-01113262, UDI: (01)008406821168552(21)TAA23050010SA(11)230130, (01)008406821168552(21)TAA23050011SA(11)230130, (01)008406821168552(21)TAA23050012SA(11)230130, (01)008406821168552(21)TAA23050013SA(11)230130; 10) 2082844-002-01113711, UDI: (01)008406821168552(21)TAA23130005SA(11)230328, (01)008406821168552(21)TAA23130007SA(11)230329, (01)008406821168552(21)TAA23130008SA(11)230329, (01)008406821168552(21)TAA23130009SA(11)230329; 11) 2082844-002-01123085, UDI: (01)008406821168552(21)TAA23190005SA(11)230513, (01)008406821168552(21)TAA23190006SA(11)230513, (01)008406821168552(21)TAA23190007SA(11)230513, (01)008406821168552(21)TAA23190008SA(11)230513, (01)008406821168552(21)TAA23190009SA(11)230513, (01)008406821168552(21)TAA23190010SA(11)230513; 12) 2082844-002-01123918, UDI: (01)008406821168552(21)TAA23130001SA(11)230328; 13) 2082844-002-01128966, UDI: (01)008406821168552(21)TAA23040022SA(11)230127; 14) 2082844-002-01133042, UDI: (01)008406821168552(21)TAA23130003SA(11)230328, (01)008406821168552(21)TAA23130004SA(11)230328, (01)008406821168552(21)TAA23130006SA(11)230329; 15) 2082844-002-01146447, UDI: (01)008406821168552(21)TAA23100001SA(11)230307; 16) 2082844-002-100205, UDI: (01)008406821168552(21)TAA23030030SA(11)230121; 17) 2082844-002-100749, UDI: (01)00840682116855(21)TAAC70272(11)230426; 18) 2082844-002-100752, UDI: (01)00840682116855(21)TAAC70075(11)230123, (01)00840682116855(21)TAAC70083(11)230124, (01)00840682116855(21)TAAC70084(11)230124, (01)00840682116855(21)TAAC70086(11)230125, (01)00840682116855(21)TAAC70087(11)230125; 19) 2082844-002-100995, UDI: (01)008406821168552(21)TAA23090003SA(11)230228, (01)008406821168552(21)TAA23090004SA(11)230228, (01)008406821168552(21)TAA23090005SA(11)230228, (01)008406821168552(21)TAA23090006SA(11)230228, (01)008406821168552(21)TAA23090002SA(11)230228, (01)008406821168552(21)TAA23090007SA(11)230228; 20) 2082844-002-101425, UDI: (01)008406821168552(21)TAA23190003SA(11)230512, (01)008406821168552(21)TAA23160001SA(11)230419, (01)008406821168552(21)TAA23170001SA(11)230424, (01)008406821168552(21)TAA23130031SA(11)230331, (01)008406821168552(21)TAA23130032SA(11)230331, (01)008406821168552(21)TAA23130033SA(11)230331, (01)008406821168552(21)TAA23130034SA(11)230331, (01)008406821168552(21)TAA23130035SA(11)230331, (01)008406821168552(21)TAA23130036SA(11)230331, (01)008406821168552(21)TAA23130021SA(11)230330, (01)00840682116855(21)TAAC70143(11)230224, (01)00840682116855(21)TAAC70144(11)230224, (01)00840682116855(21)TAAC70145(11)230224, (01)008406821168552(21)TAA23130025SA(11)230331, (01)008406821168552(21)TAA23130026SA(11)230331, (01)008406821168552(21)TAA23130027SA(11)230331, (01)008406821168552(21)TAA23130028SA(11)230331, (01)008406821168552(21)TAA23130029SA(11)230331, (01)008406821168552(21)TAA23130030SA(11)230331, (01)00840682116855(21)TAAC70146(11)230313, (01)008406821168552(21)TAA23140001SA(11)230403, (01)008406821168552(21)TAA23140002SA(11)230403, (01)008406821168552(21)TAA23130022SA(11)230330, (01)008406821168552(21)TAA23130023SA(11)230330, (01)008406821168552(21)TAA23130024SA(11)230330, (01)008406821168552(21)TAA23160002SA(11)230419; 21) 2082844-002-523548, UDI: (01)00840682116855(21)TAAW62043(11)170130; (01)00840682116855(21)TAAZ70271(11)200224; 22) 2082844-002-529928, UDI: (01)008406821168552(21)TAA23130002SA(11)230328; 23) 2082844-002-594800, UDI: (01)00840682116855(21)TAAB70352(11)220520; 24) 2082844-002-643544, UDI: (01)008406821168552(21)TAA23030023SA(11)230120, (01)008406821168552(21)TAA23030024SA(11)230120, (01)008406821168552(21)TAA23030025SA(11)230120; 25) 2082844-002-925841, UDI: (01)00840682116855(21)TAAB70547(11)220815; 26) 2082844-002-965540, UDI: (01)00840682116855(21)TAAB70617(11)220826, (01)00840682116855(21)TAAB70665(11)220928, (01)00840682116855(21)TAAB70666(11)220928, (01)00840682116855(21)TAAB70670(11)220929, (01)00840682116855(21)TAAB70671(11)220929, (01)00840682116855(21)TAAB70681(11)221003, (01)00840682116855(21)TAAB70691(11)221004, (01)00840682116855(21)TAAB70702(11)221005, (01)00840682116855(21)TAAB70703(11)221005, (01)00840682116855(21)TAAB70732(11)221010; 27) 2082844-002-982916, UDI: (01)00840682116855(21)TAAC70033(11)230113, (01)00840682116855(21)TAAC70037(11)230116, (01)00840682116855(21)TAAC70044(11)230116, (01)00840682116855(21)TAAC70052(11)230119, (01)00840682116855(21)TAAC70058(11)230119, (01)00840682116855(21)TAAC70059(11)230119, (01)00840682116855(21)TAAC70060(11)230119, (01)00840682116855(21)TAAC70065(11)230120, (01)00840682116855(21)TAAC70067(11)230123, (01)00840682116855(21)TAAC70068(11)230123, (01)00840682116855(21)TAAB70608(11)220824; 28) 2082844-002-983420, UDI: (01)00840682116855(21)TAAC70076(11)230123, (01)00840682116855(21)TAAC70078(11)230124, (01)00840682116855(21)TAAC70079(11)230124, (01)00840682116855(21)TAAC70082(11)230124, (01)00840682116855(21)TAAC70089(11)230125, (01)00840682116855(21)TAAC70090(11)230125, (01)00840682116855(21)TAAC70092(11)230126, (01)00840682116855(21)TAAC70093(11)230126; 29) 2082844-002-993905, UDI: (01)008406821168552(21)TAA23040004SA(11)230123, (01)008406821168552(21)TAA23040005SA(11)230123, (01)008406821168552(21)TAA23040006SA(11)230124, (01)008406821168552(21)TAA23050014SA(11)230130; 30) 2082844-002-995018, UDI: (01)00840682116855(21)TAAB70551(11)220815, (01)00840682116855(21)TAAB70558(11)220819; 31) 2082844-002-995799, UDI: (01)008406821168552(21)TAA23040019SA(11)230127, (01)008406821168552(21)TAA23040020SA(11)230127, (01)008406821168552(21)TAA23190004SA(11)230513, (01)008406821168552(21)TAA23160007SA(11)230420, (01)008406821168552(21)TAA23160009SA(11)230420, (01)008406821168552(21)TAA23130015SA(11)230329, (01)008406821168552(21)TAA23130016SA(11)230329, (01)008406821168552(21)TAA23130017SA(11)230329, (01)008406821168552(21)TAA23130018SA(11)230329, (01)008406821168552(21)TAA23130020SA(11)230329, (01)008406821168552(21)TAA23160003SA(11)230419, (01)008406821168552(21)TAA23160004SA(11)230419, (01)008406821168552(21)TAA23160005SA(11)230419, (01)008406821168552(21)TAA23160006SA(11)230419, (01)008406821168552(21)TAA23160008SA(11)230420, (01)008406821168552(21)TAA23160010SA(11)230420, (01)008406821168552(21)TAA23160011SA(11)230420, (01)008406821168552(21)TAA23200003SA(11)230515, (01)008406821168552(21)TAA23200004SA(11)230515, (01)008406821168552(21)TAA23200005SA(11)230515, (01)008406821168552(21)TAA23200006SA(11)230515, (01)008406821168552(21)TAA23200007SA(11)230515, (01)008406821168552(21)TAA23200008SA(11)230515, (01)008406821168552(21)TAA23200009SA(11)230515, (01)008406821168552(21)TAA23200010SA(11)230515, (01)008406821168552(21)TAA23130019SA(11)230329; 32) 2082844-002-998943, UDI: (01)00840682116855(21)TAAC70050(11)230119, (01)00840682116855(21)TAAC70053(11)230119, (01)00840682116855(21)TAAC70110(11)230130

510(k) numbers

["K213553","K152809"]

PMA numbers

not on file

Product code

FMZ

Firm FEI

3014220748

Firm city

Wauwatosa

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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