Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel ... recall (PHILIPS MEDICAL SYSTEMS)
Medical deviceClass IIOngoing
Summary: PHILIPS MEDICAL SYSTEMS is recalling Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades. 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.
What is being recalled
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide Distribution including Puerto Rico (states named: Puerto Rico)
How to tell if yours is affected
FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2650-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 11, 2026 |
| Reported | August 5, 2026 |
| Company | PHILIPS MEDICAL SYSTEMS |
| Company location | Cambridge, MA, United States |
| Initiated by | FDA Mandated |
| Quantity | 128 |
More recalls from PHILIPS MEDICAL SYSTEMS · all medical device recalls · recalls from June 2026