FDA Device Recall Z-0047-2025

DATEX--OHMEDA, INC. · Wauwatosa, WI

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

GE Heathcare Giraffe OmniBed; neo natal incubator

Lot / serial / GTIN: 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.

Recall record

Recall number: Z-0047-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution.
Recall initiated: 2024-09-03
Classified by FDA Center: 2024-10-17
FDA published: 2024-10-23
Recalling firm: DATEX--OHMEDA, INC.
Firm location: Wauwatosa, WI

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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