CLASS I Device recall · Reported 11 Dec 2019 · FDA Enforcement Report

Giraffe Incubator infant warmer recalled by GE Healthcare

GE Healthcare is recalling Giraffe Incubator infant warmer. The recall was initiated on 11 Oct 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel Numbers: 6651-XXXX-XXX 2074921-00X-XXXXXX M1050206 M1050207 M1136120 M1136222 M1136226 M1138367 M1145526 M1145527 M1146091 M1146092 M1148634 M1161351 M1161353 M1161357 M1206149 M1235958 Updated 6/3/2021 - All model numbers and units are affected.

Quantity recalled19425 units

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-0541-2020
FDA event ID: 84077
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class I
Status: Terminated
Recall initiated: 11 Oct 2019
FDA classified: 3 Dec 2019
Reported: 11 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Oct 2019	Recall initiated by company
3 Dec 2019	Classified by FDA	+53 days
11 Dec 2019	Published in enforcement report	+8 days

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

Reason for recall

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

Product as listed by the FDA

Giraffe Incubator infant warmer

Where it was distributed

worldwide

Questions about this recall

Why was it 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.

Which lots are affected?

Model Numbers: 6651-XXXX-XXX 2074921-00X-XXXXXX M1050206 M1050207 M1136120 M1136222 M1136226 M1138367 M1145526 M1145527 M1146091 M1146092 M1148634 M1161351 M1161353 M1161357 M1206149 M1235958 Updated 6/3/2021 - All model numbers and units are affected.

Where was it sold?

worldwide

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

3 other products · FDA event 84077

This product is part of a recall event; the main page for the event is Giraffe Incubator Carestation recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
11 Dec 2019	CLASS I	Giraffe Incubator Carestation recalled by GE Healthcare	GE Healthcare	Other	WI
11 Dec 2019	CLASS I	Giraffe OmniBed infant warmer recalled by GE Healthcare	GE Healthcare	Other	WI
11 Dec 2019	CLASS I	Giraffe OmniBed Carestation recalled by GE Healthcare	GE Healthcare	Other	WI

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