FDA DevicesClass II
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All ...
Published: June 24, 2026Recall ID: Z-2475-2026Category: 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, a combination of an infant incubator and an infant warmer, All Models
Additional Source Details
| Field | Value |
|---|---|
| City | Waukesha |
| State | WI |
| Event id | 98986 |
| Address 1 | 3000 N Grandview Blvd |
| Code info | Serial Numbers: HDGP50034 HDGP51018 HDGS50069 HDGS50070 HDGS50074 HDGS50077 HDGS50158 HDGS50162 HDGS52245 HDGS52286 HDGT50374 HDGT50399 HDGS50464 HDGS50560 HDGS50569 HDGS50570 HDGD50349 HDGG54079 HDGJ50278 HDGJ50281 HDGJ50390 HDGJ50391 HDGJ50394 HDGJ50400 HDGK52363 HDGM50481 HDGM50482 HDGM50483 HDGM50484 HDGM50485 HDGM50486 HDGQ50625 HDGQ50626 HDGQ50627 HDGQ50628 HDGQ50629 HDGS50369 HDGS50370 HDGS50371 HDGS50372 HDGR50086 HDGL51597 HDGG54268 HDGG54270 HDGG54410 HDGK51696 HDGL51002 HDGL51003 HDGL51004 HDGL51005 HDGL51032 HDGN50383 HDGP50522 HDGQ50763 HDGQ50882 HDGQ50884 HDGQ50886 HDGQ50887 HDGQ50901 HDGQ50902 HDGQ50903 HDGQ50904 HDGQ50905 HDGQ50906 HDGQ50907 HDGQ50908 HDGQ50909 HDGQ50910 HDGQ50911 HDGQ50912 HDGQ50913 HDGQ50917 HDGS51833 HDGU60609 HDGU60732 HDGE50297 HDGE50370 HDGE50371 HDGK51791 HDGK51792 HDGK51793 HDGK51794 HDGK51795 HDGK51804 HDGK51822 HDGK51840 HDGR50087 HDGR50088 HDGR50178 HDGR50180 HDGR50184 HDGR50185 HDGN50863 HDGN50864 HDGN50865 HDGN50866 HDGN50868 HDGN50869 HDGN... [TRUNCATED] |
| Postal code | 53188-1615 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 19587 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.