FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
- Recall number
- Z-2477-2026
- Recalling firm
- GE Medical Systems, LLC
- Product
- Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
- Status
- Open, Classified
- Initiated
- 2026-05-01
- Posted
- 2026-06-17
- Terminated
- not on file
- 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.
- Root cause
- Component design/selection
- Action
- 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.
- Quantity
- 265 units
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382
- 510(k) numbers
- ["K020543","K101788","K152814","K213551"]
- PMA numbers
- not on file
- Product code
- FMZ
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28