Recall Z-2477-2026— GE Medical Systems, LLC

Name: FDA recall Z-2477-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-01

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2026-05-01. It names 4 FDA 510(k) clearances: K213551, K152814, K101788 and 1 more. Product: Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500. Reason: GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-05-01
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

4 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
K101788 — GIRAFFE OMNIBEDOhmeda Medical·cleared 2010-07-21
K020543 — OHMEDA MEDICAL GIRAFFE OMNIBEDOhmeda Medical·cleared 2002-05-09

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

Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

Reason for recall

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

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