Omni Legend System Images
- Recalling firm
- GE Healthcare Limited
- Product
- Omni Legend System Images. [Device]. Model: Omni Legend PET/CT, all configurations using Software version SP5,SP6,SP7,SP8
- Reason
- 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.)
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-12
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/520f901b-3d22-4c37-be6d-c040fe7270e7