FDA recall, , Moderate risk
Philips CT Scanners
The CT scan may not trigger automatically after Bolus Tracking, causing inadequate diagnosis and potential rescan.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems of Cambridge, Massachusetts, recalled its IQon Spectral CT, Brilliance iCT, Ingenuity CT, and related CT upgrades. 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, which may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation. The company began the recall on June 11, 2026, and it was added to the FDA's Enforcement Report on July 27, 2026. Distribution was nationwide, including Puerto Rico.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
IQon Spectral CT IQon Spectral CT Upgrades
- UDI-DI
- 00884838059542
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
- UDI-DI
- 00884838059474
- 00884838104600
- 00884838083325
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
- UDI-DI
- 00884838059498
- 00884838059504
- 00884838059511
- 00884838098701
- 00884838059863
Recall details
- Company began the recall
- Sold in
US Nationwide Distribution including Puerto Rico
- Company
- PHILIPS MEDICAL SYSTEMSCambridge, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99352
- Recall numbers
- Z-2650-2026 to Z-2652-2026
All recalls from PHILIPS MEDICAL SYSTEMS
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
