Recall Z-2650-2026 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS MEDICAL SYSTEMS
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
| Date | Jul 27, 2026 (initiated Jun 11, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | An Electronic Product Radiation Correction letter was issued to its customers describing the product, problem and actions to be taken by its customers. To identify the software version of your product: 1. Click the Help button. 2. Select About and the software version is then displayed. The software version begins with v. 3.You may continue to use your system(s) in accordance with the intended use. 4. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Electronic Product Radiation Correc |
| Quantity | 128 |
| Distribution | US Nationwide Distribution including Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K250648 | Philips iCT CT system Philips Medical Systems Nederland B.V., Jun 27, 2025 |