CLASS I ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report

GE Heathcare Giraffe OmniBed recalled by Datex--ohmeda

Datex--ohmeda is recalling GE Heathcare Giraffe OmniBed. The recall was initiated on 3 Sep 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll models

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0047-2025
FDA event ID: 95282
Recalling firm: Datex--ohmeda, Wauwatosa, WI
Classification: Class I
Status: Ongoing
Recall initiated: 3 Sep 2024
FDA classified: 17 Oct 2024
Reported: 23 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

3 Sep 2024	Recall initiated by company
17 Oct 2024	Classified by FDA	+44 days
23 Oct 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

GE Heathcare Giraffe OmniBed; neo natal incubator

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

All models

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 95282

Reported	Class	Recall	Company	Reason	Where
23 Oct 2024	CLASS I	GE Heathcare Giraffe OmniBed Carestation recalled by Datex--ohmeda	Datex--ohmeda	Device Malfunction	WI

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23 Sep 2026Device	CLASS II	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide
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24 Jun 2026Device	CLASS I	Panda Freestanding Warmer, Infant Radiant Warmer Product recalled	Datex-Ohmeda	Device Malfunction	WI

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