medical HIGH RISK Updated 2024-10-23

DATEX--OHMEDA, INC. recalls GE Heathcare Giraffe OmniBed Carestation, Model Number 20828

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: All models

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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