FDAClass IOctober 23, 2024

GE Heathcare Giraffe OmniBed Carestation recall

GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator

Why was GE Heathcare Giraffe OmniBed Carestation 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 I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All models

Product
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Recalling firm
DATEX--OHMEDA, INC.
Distribution
Worldwide distribution.
Recall date
October 23, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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