Use cautionMedical device recall · FDA · Published September 3, 2024
GE HealthCare Giraffe OmniBed Incubator Recall: Loose Doors Risk Injury
GE HealthCare recalls Giraffe OmniBed neonatal incubators due to potential loose doors from improper screw tightening. Affected units may require repair to prevent injury risks during use.
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.
Take action
Contact the company
📍Recalling firmDATEX--OHMEDA, INC.9900 W Innovation Dr · Wauwatosa, WI 53226-4856
“GE HealthCare Giraffe OmniBed Incubator Recall: Loose Doors Risk Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54114-ge-healthcare-giraffe-omnibed-incubator-recall-loose-doors-risk-injury. Based on FDA recall #Z-0047-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0047-2025%22&limit=1).
The FDA announced on September 3, 2024, that Datex-Ohmeda Inc. is recalling certain GE HealthCare Giraffe OmniBed neonatal incubators due to a Class I hazard. The doors covering the warmer heaters may become loose because the securing screw was not torqued to specification.
The screw securing the doors that cover the warmer heaters may not have been torqued to specification. This defect may lead to the doors becoming loose.
Context
GovInfoNow's records show Datex-Ohmeda Inc. has had 8 other recalls on record since December 8, 2017. Other recent recalls of similar products include a Giraffe OmniBed FRU recall for risk of patient injury from a loose canopy soffit (May 1, 2026) and an Aisys CS2 Anesthesia System recall for interrupted anesthetic delivery (July 30, 2026).
How to tell if you have this one
Check for GE HealthCare Giraffe OmniBed neonatal incubators with any model number. The recall applies to all models of this product.
Brand
Datex-Ohmed: GE HealthCare
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Worldwide distribution.
Recall number
Product, codes & lots
Quantity
Z-0047-2025
GE Heathcare Giraffe OmniBed; neo natal incubator; All models
—
Z-0048-2025
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator; All models
—
Based on the official FDA remedy
What to do — step by step
Check for Loose Doors
Inspect the doors covering the warmer heaters for looseness. If loose, stop using the incubator immediately.
Contact Manufacturer
Reach out to GE HealthCare for repair instructions or to confirm if your unit is affected.
How this recall unfolded
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0047-2025 (September 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0047-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.