Z-2651-2026 Class II Ongoing
FDA device recall Z-2651-2026 was initiated by PHILIPS MEDICAL SYSTEMS on June 11, 2026 and is designated Class II. Reason for recall: 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 acqui… The recall status is ongoing. Affected quantity: 42.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2026
- Initiation Date
- June 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 42
Product Description
IQon Spectral CT IQon Spectral CT Upgrades
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution including Puerto Rico
Code Information
FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542