RecallRadar

FDA Device recall Z-0538-2020

Giraffe OmniBed infant warmer

On 2019-12-11 the FDA classified a Class I recall of Giraffe OmniBed infant warmer by Ge Healthcare, citing giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0538-2020
ClassificationClass I
Statusterminated
Initiated2019-10-11
Published2019-12-11
Last updated2026-09-13 11:55 UTC
CompanyGe Healthcare
Distributionn/a

Product

Giraffe OmniBed infant warmer

Reason

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

Identifiers

code_info
Model Numbers: 6650-0XXX-XXX 2074920-00X-XXXXXX M1050205 M1136116 M1136215 M1139253 M1145528 M1145529 M1146094 M1149051…Model Numbers: 6650-0XXX-XXX 2074920-00X-XXXXXX M1050205 M1136116 M1136215 M1139253 M1145528 M1145529 M1146094 M1149051 M1149079 M1149081 M1149087 M1149108 M1161324 M1161328 M1161338 M1162796 M1206147 M1235957 Updated 6/3/2021 - All model numbers and units are affected.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0538-2020%22

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