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Recall Observatory FDA recall evidence

Device product

Giraffe Incubator infant warmer

Z-0541-2020

October 11, 2019

Class I

Product summary

Firm
GE Healthcare, LLC
Event
Event 84077
Status
Terminated
Classification
Class I
Quantity
19425 units
Official record key
device-enforcement:Z-0541-2020

Official wording

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.

Code information: 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.

Distribution pattern: worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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