Official recall notice
FDA DeviceClass IINotable
FDA Recall: IQon Spectral CT IQon Spectral CT Upgrades
- 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
FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542