DATEX--OHMEDA, INC. recalls GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator

Recall date

September 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0048-2025

FDA classification

Class I

Brand / firm

DATEX--OHMEDA, INC.

Sold / distributed

Worldwide distribution.

Why it was recalled

GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.

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

GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator