PHILIPS MEDICAL SYSTEMS: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades

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.

Details from the source

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: US Nationwide Distribution including Puerto Rico Quantity: 128 Lot/code info: FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232

UPC codes

00884838059474, 00884838104600, 00884838083325

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.