Class IIDeviceOngoing

Philips North America Llc

Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

Reason for recall

The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.

Details

Recall number: Z-3155-2026
Event ID: 99865
Recall initiated: Aug 18, 2026
Classified: Sep 29, 2026
Reported: Oct 7, 2026
Quantity: 62
Distribution: U.S. and U.S. Territories.
Initiated by: FDA Mandated
Firm location: Cambridge, MA, United States
Lot / code info: UDI: (01)00884838101111