Recall Z-0048-2025— DATEX--OHMEDA, INC.

Name: FDA recall Z-0048-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-03

Class I · Ongoing

Class I FDA medical device recall by DATEX--OHMEDA, INC., initiated 2024-09-03. It names 2 FDA 510(k) clearances: K213551, K152814. Product: GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator. Reason: 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..

Recalling firm: DATEX--OHMEDA, INC.
Classification: Class I
Status: Ongoing
Initiated: 2024-09-03
Firm location: Wauwatosa, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K213551 — Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.·cleared 2022-03-02
K152814 — Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company·cleared 2016-03-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.