IQon Spectral CT IQon Spectral CT Upgrades recall (PHILIPS MEDICAL SYSTEMS)
Medical deviceClass IIOngoing
Summary: PHILIPS MEDICAL SYSTEMS is recalling IQon Spectral CT IQon Spectral CT 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
IQon Spectral CT IQon Spectral CT 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 728331 728332, DI (01)00884838059542
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-2651-2026 |
| 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 | 42 |
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