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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: 182 Lot/code info: FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325

UPC codes

00884838059498, 00884838059504, 00884838059511, 00884838098701, 00884838059863

Source

Official record: FDA (Device enforcement) ↗

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