Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36468 |
| Brand Name: | Omni Legend System Images |
| Model: | Omni Legend PET/CT, all configurations using Software version SP5,SP6,SP7,SP8 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
| Contact Information: | 0800 659 465 |
| Manufacturer: | GE Medical Systems Functional Imaging Haifa |
| Issue: | The manufacturer has become aware of a potential intermittent issue 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 issue.) |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/1/2026 |
