The Recall Desk
SevereFDA (Devices)·Z-0048-2025·Announced 2024-10-23

GE HealthCare Recalls Giraffe OmniBed Carestations Due to Door Screw Issue

GE HealthCare is recalling certain Giraffe OmniBed Carestations because a screw securing the heater doors may not be torqued to specification, potentially causing the doors to become loose.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 according to the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.

Plain-English summary

GE HealthCare is recalling certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, including the Model Number 2082844-001-XXX. The recall involves a manufacturing issue where the screw that secures the doors covering the warmer heaters may not have been torqued to the required specification.

This defect may lead to the doors becoming loose. The source text does not specify the number of units affected, the specific dates of manufacture, or the geographic distribution beyond noting worldwide distribution in the metadata. No illnesses or injuries have been reported in the source text.

Healthcare facilities should contact GE HealthCare for instructions on how to address this issue. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death, although the specific mechanism of harm is not detailed in the provided text.

The recalled product

Product
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Manufacturer
DATEX--OHMEDA, INC.
Category
Medical Device — Neonatal Incubator
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All models

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by DATEX--OHMEDA, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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