| TGA Action ID |
RC-2026-RN-00018-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Omni Legend PET/CT
All configurations using software version SP5, SP6, SP7, SP8
GTIN: 00195278454218, 00195278592309, 00195278792822, 00195278901439 |
| ARTG Number |
400263 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
GE HealthCare has become aware of a potential intermittent problem on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. In some cases, the artifact can mimic pathology and has the potential to lead to misdiagnosis if undetected. (Note: Standalone CT image acquisition is not impacted by this problem.)
There have been no injuries reported as a result of this problem. |
| Instructions for Customers/Users |
A GE representative will contact customers to arrange for the correction. |
| Action Commencement Date |
19/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE Healthcare |