Device recall: Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822…

Class II FDA enforcement event 92454. Recall start date: 19 May 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

DATEX--OHMEDA, INC. started this device recall on 19 May 2023. The firm address in the FDA record is in Wauwatosa, WI. FDA put the recall in Class II. FDA event 92454 has 3 product records. The first FDA enforcement report date is 12 Jul 2023. The record gives the status Ongoing.

FDA enforcement report The 3 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution.

Recalling firm

DATEX--OHMEDA, INC., Wauwatosa, WI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

3 product records in the event.

FDA event 92454: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2100-2023	Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G…	4,540 units	Class II	Ongoing	12 Jul 2023
Z-2101-2023	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,…	3,053 units	Class II	Ongoing	12 Jul 2023
Z-2102-2023	Beside panel FRU (Field Replacement Units) Kits	18	Class II	Ongoing	12 Jul 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class II: 88%
Product records in this event: 3Median of the firm: 3
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of DATEX--OHMEDA, INC.
Initiated	Product (first record)	Type	Class	Records
30 Jul 2026	Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000	Device	Class II	4
8 May 2026	Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 208266	Device	Class I	3
3 Sep 2024	GE Heathcare Giraffe OmniBed; neo natal incubator	Device	Class I	2
12 Jul 2024	Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to	Device	Class I	11
29 Dec 2023	EVair air compressor, model numbers: M1230849 and M1230847	Device	Class I	3
6 Jun 2023	GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844	Device	Class I	2
28 Jun 2018	The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neona	Device	Class II	1
8 Dec 2017	CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to prov	Device	Class II	1

DATEX--OHMEDA, INC.: all 9 events

Official channels

FDA enforcement report Z-2100-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 92454. https://recallregister.com/fda/ii/92454/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution.
What quantity of product is in FDA event 92454?: The event has 3 product records. The first record gives this quantity: 4,540 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 88% of the 917 device events that started in 2023 are in Class II.