CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report

Giraffe OmniBed, with the following recalled by Datex--ohmeda

Datex--ohmeda is recalling Giraffe OmniBed, with the following. The recall was initiated on 19 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lot/Serial Numbers

Quantity recalled3,053 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-2101-2023
FDA event ID: 92454
Recalling firm: Datex--ohmeda, Wauwatosa, WI
Classification: Class II
Status: Ongoing
Recall initiated: 19 May 2023
FDA classified: 6 Jul 2023
Reported: 12 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 May 2023	Recall initiated by company
6 Jul 2023	Classified by FDA	+48 days
12 Jul 2023	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 of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

Product as listed by the FDA

Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650-0082-902, 6650-0061-902, 6650-0131-902, 6650-0034-902, 6650-0104-902, 6650-0066-902, 6650-0042-902, 6650-0143-901, 6650-0148-902, 6650-0152-901, 6650-0107-902, 6650-0136-902, 6650-0060-902, 6650-0056-902, 6650-0043-902. Labeled as OMNIBED ENG EBASE S-HUMID, GIRAFFE OMNIBED, GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, OMNIBED SW EBASE S-HUMID, Giraffe OmniBed Legacy, OMNIBED FR EBASE S-HUMID, OMNIBED GR EBASE S-HUMID, OMNIBED SP EBASE S-HUMID, ASSY-LAU, OMNIBED ENG EBASE S-HUMI D, Finished good - Make, OBSOLETE-OMNIBED UK EBASE S-HUMID, OMNIBED UK EBASE S-HUMID. Incubator, Neonatal

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

All Lot/Serial Numbers

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

2 other products · FDA event 92454

This product is part of a recall event; the main page for the event is Giraffe OmniBed Carestation CS1 recalled by Datex--ohmeda.

Reported	Class	Recall	Company	Reason	Where
12 Jul 2023	CLASS II	Giraffe OmniBed Carestation CS1 recalled by Datex--ohmeda	Datex--ohmeda	Other	WI
12 Jul 2023	CLASS II	Beside panel FRU (Field Replacement Units) Kits recalled	Datex--ohmeda	Other	WI

More recalls from Datex--ohmeda

All 30

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Aisys, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Aisys CS2, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS I	Panda Freestanding Warmer, Infant Radiant Warmer Product recalled	Datex-Ohmeda	Device Malfunction	WI

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