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Recall Observatory FDA recall evidence

Device product

Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer

Z-0539-2020

October 11, 2019

Class I

Product summary

Firm
GE Healthcare, LLC
Event
Event 84077
Status
Terminated
Classification
Class I
Quantity
7814 units
Official record key
device-enforcement:Z-0539-2020

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 OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX 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.