RecallRadar

FDA Device recall Z-0541-2020

Giraffe Incubator infant warmer

On 2019-12-11 the FDA classified a Class I recall of Giraffe Incubator 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-0541-2020
ClassificationClass I
Statusterminated
Initiated2019-10-11
Published2019-12-11
Last updated2026-09-13 11:55 UTC
CompanyGe Healthcare
Distributionn/a

Product

Giraffe Incubator 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: 6651-XXXX-XXX 2074921-00X-XXXXXX M1050206 M1050207 M1136120 M1136222 M1136226 M1138367 M1145526 M114552…Model Numbers: 6651-XXXX-XXX 2074921-00X-XXXXXX M1050206 M1050207 M1136120 M1136222 M1136226 M1138367 M1145526 M1145527 M1146091 M1146092 M1148634 M1161351 M1161353 M1161357 M1206149 M1235958 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-0541-2020%22

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