Summary
The FDA issued a Class I for GE Heathcare Giraffe OmniBed; neo natal incubator by DATEX--OHMEDA, INC.. Reason: GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover t.
Details
Source
Device Recall
External ID
Z-0047-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
GE Heathcare Giraffe OmniBed; neo natal incubator
Lot/Code Info: All models
Reason for Recall
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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-03
Company
Wauwatosa, WI
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DATEX--OHMEDA, INC. has 29 FDA actions in our database, including 24 recalls and 5 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DATEX--OHMEDA, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DATEX--OHMEDA, INC. have FDA actions?
DATEX--OHMEDA, INC. has 29 FDA actions in our database, including 24 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0047-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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