Giraffe OmniBed, with the following Model Numbers:… recallZ-2101-2023 · Datex--Ohmeda, Inc. · initiated May 19, 2023

Class II Open, Classified All recalls posted in July 2023

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Datex--Ohmeda, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees beginning on 05/19/2023 by mail. The notice explained the problem, risk, and requeested the following: Actions to be taken by Customer/User: Inspect the device bedside panels; if the device has the correct latches, continue to use the device. If the device does not have the correct latches, quarantine the device. Inspect any field replaceable bedside panel stock and quarantine for the affected product. GE Healthcare will replace affected latches.

Recall details

Recall number: Z-2101-2023
Recall class: Class II
Status: Open, Classified
Initiated by the company: May 19, 2023
Posted by the FDA: Jul 6, 2023
Recalling firm: Datex--Ohmeda, Inc.
Quantity: 3,053 units
Product code: FMZ
FDA submissions: K020543, K101788
Distribution: Worldwide distribution.

Product description

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

Code information (models, lots, serial numbers)

All Lot/Serial Numbers

Other devices under the same FDA submission

1 device cleared under K020543, K101788 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Giraffe OmniBed Carestation CS1
Datex-Ohmeda, Inc. · INCUBATOR, NEONATAL
2 recalls217 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92454).

Z-2100-2023 · Open, Classified
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, …

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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