Z-2477-2026 Class II Ongoing
FDA device recall Z-2477-2026 was initiated by GE Medical Systems, LLC on May 1, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 265 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- May 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 265 units
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382