Recall Z-0140-2025

Datex--Ohmeda, Inc. · initiated June 6, 2023

Class I Completed

Class I – dangerous or defective products that could cause serious health problems or death

Product

GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2082844-001-01069008; 8) 2082844-001-01073750; 9) 2082844-001-01086553; 10) 2082844-001-01089393; 11) 2082844-001-01090414; 12) 2082844-001-01092632; 13) 2082844-001-01111482; 14) 2082844-001-01115741; 15) 2082844-001-01122391; 16) 2082844-001-01128579; 17) 2082844-001-01128725; 18) 2082844-001-01131573; 19) 2082844-001-01140642; 20) 2082844-001-01165870; 21) 2082844-001-100397; 22) 2082844-001-100676; 23) 2082844-001-100740; 24) 2082844-001-100743; 25) 2082844-001-100744; 26) 2082844-001-101075; 27) 2082844-001-101149; 28) 2082844-001-101199; 29) 2082844-001-101202; 30) 2082844-001-101203; 31) 2082844-001-101356; 32) 2082844-001-101366; 33) 2082844-001-101656; 34) 2082844-001-102136; 35) 2082844-001-102589; 36) 2082844-001-102858; 37) 2082844-001-526493; 38) 2082844-001-533346; 39) 2082844-001-570904; 40) 2082844-001-615985; 41) 2082844-001-616544; 42) 2082844-001-674814; 43) 2082844-001-701655; 44) 2082844-001-704407; 45) 2082844-001-709042; 46) 2082844-001-857748; 47) 2082844-001-888278; 48) 2082844-001-941288; 49) 2082844-001-965539; 50) 2082844-001-978713; 51) 2082844-001-982099; 52) 2082844-001-982310; 53) 2082844-001-982985; 54) 2082844-001-982988; 55) 2082844-001-983509; 56) 2082844-001-983643; 57) 2082844-001-983679; 58) 2082844-001-984096; 59) 2082844-001-984948; 60) 2082844-001-987480; 61) 2082844-001-987855; 62) 2082844-001-993967; 63) 2082844-001-994441; 64) 2082844-001-995782; 65) 2082844-001-998377; Radiant infant warmer

Codes / lots: 1) 2082844-001-01040418, UDI: (01)00840682116862(21)TABC70024(11)230203, (01)00840682116862(21)TABC70035(11)230207, (01)00840682116862(21)TABC70037(11)230207, (01)00840682116862(21)TABC70038(11)230207, (01)00840682116862(21)TABC70045(11)230208, (01)00840682116862(21)TABC70052(11)230209, (01)00840682116862(21)TABC70054(11)230209, (01)00840682116862(21)TABC70056(11)230209, (01)00840682116862(21)TABC70060(11)230209, (01)00840682116862(21)TABC70064(11)230210, (01)00840682116862(21)TABC70068(11)230210, (01)00840682116862(21)TABC70069(11)230210, (01)00840682116862(21)TABC70070(11)230210; 2) 2082844-001-01046784, UDI: (01)008406821168622(21)TAB23060007SA(11)230209, (01)008406821168622(21)TAB23060008SA(11)230209, (01)008406821168622(21)TAB23060009SA(11)230209, (01)008406821168622(21)TAB23060010SA(11)230209, (01)008406821168622(21)TAB23060011SA(11)230209, (01)008406821168622(21)TAB23060012SA(11)230209, (01)008406821168622(21)TAB23060013SA(11)230209, (01)008406821168622(21)TAB23060014SA(11)230209, (01)008406821168622(21)TAB23060015SA(11)230209; 3) 2082844-001-01052324, UDI: (01)00840682116862(21)TABC70169(11)230228; 4) 2082844-001-01052572, UDI: (01)00840682116862(21)TABC70101(11)230215…

Reason for recall

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.

FDA-determined cause: Component design/selection

Action taken

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

Details

Recall number
Z-0140-2025
Initiated
June 6, 2023
Posted by FDA
October 31, 2024
Product code
FMZ – Incubator, Neonatal
Quantity
769 units
Distribution
worldwide
Recalling firm
Datex--Ohmeda, Inc., Wauwatosa, WI

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0141-2025 Class IGE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)…Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from… 06/06/2023Completed