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Recall Observatory FDA recall evidence

Device product

Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer

Z-0540-2020

October 11, 2019

Class I

Product summary

Firm
GE Healthcare, LLC
Event
Event 84077
Status
Terminated
Classification
Class I
Quantity
3467 units
Official record key
device-enforcement:Z-0540-2020

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: Giraffe Incubator Carestation, Model Numbers:2082844-002-XXXXXX 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.