Device recall
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
- Recall number
- Z-3155-2026
- Event id
- 99865
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Philips North America Llc
- Report date
- Oct 7, 2026
- Posted
- Sep 29, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Sep 29, 2026
- Product code
- JAK
- Device type
- System, X-Ray, Tomography, Computed
- Reason
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Quantity
- 62
- Code info
- UDI: (01)00884838101111
- Distribution
- U.S. and U.S. Territories.
- Voluntary or mandated
- FDA Mandated
- Related 510(k)s
- K244008
- Location
- Cambridge, MA, United States