Recall Z-3155-2026 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
| Date | Sep 29, 2026 (initiated Aug 18, 2026) |
| Status | Open, Classified |
| 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 |
| Action | Philips sent an Electronic Product Radiation Correction notification dated August 18, 2026 to the users of the affected systems to alert them of the issue and provide the actions that should be taken in order to prevent risks to patients. Philips will schedule an appointment with customers to install a software solution free of charge. |
| Quantity | 62 |
| Distribution | U.S. and U.S. Territories. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K244008 | Spectral CT Philips Medical Systems Technologies , Ltd., May 16, 2025 |