GE Heathcare Giraffe OmniBed recallZ-0047-2025 · Datex--Ohmeda, Inc. · initiated Sep 3, 2024
Class I Open, Classified All recalls posted in October 2024
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 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.
FDA root cause category: Use error
What the company is doing
GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/03/2024 via Fed-Ex. The notice explained the problem with the device, safety issue, and requested the following: Download the Service Manual Addendum (5971733) from the GE HealthCare Customer Documentation Portal: https://www.gehealthcare.com/support/manuals. Inspect the heater door mounting screw on your device. If the screw is not appropriately tightened, complete steps 9 and 10 of Section 1.1 of the Service Manual Addendum (5971733).
Recall details
- Recall number
- Z-0047-2025
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Sep 3, 2024
- Posted by the FDA
- Oct 17, 2024
- Recalling firm
- Datex--Ohmeda, Inc.
- Product code
- FMZ
- FDA submissions
- K101788, K020543
- Distribution
- Worldwide distribution.
Product description
GE Heathcare Giraffe OmniBed; neo natal incubator
Code information (models, lots, serial numbers)
All models
Other devices under the same FDA submission
1 device cleared under K101788, K020543 — 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 CS1Datex-Ohmeda, Inc. · INCUBATOR, NEONATAL2 recalls217 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95282).
- Z-0048-2025 · Open, ClassifiedGE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
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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