Official recall notice
FDA DeviceClass IINotable
Philips Medical Systems Recall (Oct 2026)
Product: Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
- Recall date
- 2026-10-07
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
UDI: (01)00884838101111