Official recall notice
FDA Recall: Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Up
- Recall date
- 2026-08-05
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
Product description
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
Affected products
FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325