Medical device recalls High risk

GE Healthcare, LLC recalls Giraffe OmniBed infant warmer

Recall date
October 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0538-2020
FDA classification
Class I
Brand / firm
GE Healthcare, LLC
Sold / distributed
worldwide

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Giraffe OmniBed infant warmer

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