| TGA Action ID |
RC-2025-RN-00828-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Giraffe OmniBed and Giraffe OmniBed Carestation devices
All Giraffe OmniBed Carestations manufactured between January 2018 and
July 2025 and Giraffe OmniBeds and Giraffe OmniBed Carestations that
have had heater doors replaced during this time frame. |
| ARTG Number |
309228 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification, causing the doors to become loose. If the doors become loose, the system may activate a high priority alarm, and the canopy movement will stop.
If loose doors are observed, the canopy should not be moved, and the system should not be put into clinical use until service is performed. Continuing to force the canopy to move may damage the canopy and, in rare cases, might cause the heater door to fall, potentially causing injury to the patient. The user manual includes instructions to prevent this problem.
No injuries have been reported as a result of this potential problem.
This market action is an update to the Urgent Product Correction (TGA Ref: RC-2024-RN-00828-1) to notify of the additional affected products. |
| Instructions for Customers/Users |
Customers are to:
Inspect affected devices for loose heater doors.
- If a loose door is found, even without an alarm, take the system out of clinical use and contact a GE Healthcare Service Representative.
- If no defect is found, continue to use the device following the pre-use checkout steps in the User Manual.
Refer to the Service Manual Addendum for instructions on installing and tightening the heater door screw.
GE HealthCare will provide replacement heater doors if required.
This action has been closed out on 26/05/2026 |
| Action Commencement Date |
30/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE HealthCare Service |