Z-2650-2026 Class II Ongoing
FDA device recall Z-2650-2026 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: 128.
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
- 128
Product Description
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 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 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232