DATEX--OHMEDA, INC.: Device Recall

Recall #Z-0048-2025 · 09/03/2024

Class I: Dangerous

Recall Details

Recall Number: Z-0048-2025
Classification: Class I
Product Type: Device
Recalling Firm: DATEX--OHMEDA, INC.
Status: Ongoing
Date Initiated: 09/03/2024
Location: Wauwatosa, WI, United States
Voluntary/Mandated: Voluntary: Firm initiated

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.

Product Description

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

Distribution Pattern

Worldwide distribution.

Other Recalls by DATEX--OHMEDA, INC.

Class I: Dangerous 09/03/2024

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.
Class I: Dangerous 07/12/2024

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Class I: Dangerous 07/12/2024

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Class I: Dangerous 07/12/2024

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Class I: Dangerous 07/12/2024

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

View all recalls by DATEX--OHMEDA, INC. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.