GE Medical Systems, LLC recalls Giraffe OmniBed Field Replaceable Unit (FRU)

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.

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 5/1/26 was sent to customers. Actions to be taken by Customer/User You may continue to use your device after performing the pre-use checkout in accordance with the Giraffe OmniBed Carestation User Manual (Chapter 6 Pre-Use Checkout). During the pre-use checkout described in the product User Manual, visually inspect the device for any damaged or missing components. This includes verifying that the canopy soffit is properly secured and that all six fasteners are present and fully engaged. If you observe damage, missing fasteners, or improper soffit attachment during the pre-use checkout, please remove the device from clinical use and contact GE HealthCare Service. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please complete and return the attached acknowledgement form electronically via FMI 32101 Digital CRF or print, fill out manually, scan, and email to MIC.FMI32101@gehealthcare.com. Please retain this document for your records. Product Correction GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. Contact Information If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact GE HealthCare per the contact information above.

• FDA enforcement recordOfficial FDA database entry for Z-2477-2026
• FDA 510(k) clearance · K020543The device's official FDA premarket clearance record
• FDA 510(k) clearance · K101788The device's official FDA premarket clearance record
• FDA 510(k) clearance · K152814The device's official FDA premarket clearance record
• FDA 510(k) clearance · K213551The device's official FDA premarket clearance record
• FDA device classification · FMZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5400The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GE Medical Systems, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.