The Recall Desk
SevereFDA (Devices)·Z-0047-2025·Announced 2024-10-23

GE HealthCare Giraffe OmniBed neonatal incubator door screw may loosen

Certain GE HealthCare Giraffe OmniBed and Carestation neonatal incubators may have door-securing screws that were not torqued to specification, potentially causing the doors to become loose. These units are distributed worldwide.

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: This is an FDA Class I medical device recall, which establishes a minimum severity of 4 per the rubric. Although no injuries or illnesses have been reported, the potential for doors to loosen on neonatal incubation equipment presents a safety concern in a critical care environment.

Plain-English summary

GE HealthCare Giraffe OmniBed and Giraffe OmniBed Carestation neonatal incubators are subject to a Class I recall. The manufacturer has identified that certain units may have doors covering the warmer heaters that are not properly secured due to screws that were not torqued to specification.

If the screws are not properly torqued, the doors covering the warmer heaters may become loose during operation. This creates a potential safety hazard in a neonatal intensive care setting.

The recall affects certain Giraffe OmniBed and Giraffe OmniBed Carestation units that have been distributed worldwide.

The recalled product

Product
GE Heathcare Giraffe OmniBed; neo natal incubator
Manufacturer
DATEX--OHMEDA, INC.
Category
Medical Device — Neonatal Equipment
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 →

Related recalls

Same manufacturer · DATEX--OHMEDA, INC.

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