FDA DevicesClass II
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 66...
Published: June 24, 2026Recall ID: Z-2477-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98986 |
| Address 1 | 3000 N Grandview Blvd |
| Code info | Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382 |
| Postal code | 53188-1615 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 265 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260501 |
| Initial firm notification | Letter |
| Center classification date | 20260617 |
Overview
- Recalling FirmGE Medical Systems, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.