FDA Medical devices recall ·
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0048-2025
- Date
- (initiated September 3, 2024)
- Company / brand
- Datex-Ohmeda, Inc.
9900 W Innovation Dr, Wauwatosa, WI, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All models
Distribution
Worldwide distribution.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0048-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.