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.
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: 42 Lot/code info: FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542
00884838059542
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.