Philips Medical Systems: System, X-ray, Tomography, Computed
Recall Summary Philips IQon Spectral CT scanners and upgrades may fail to automatically start clinical scans after a Bolus Tracking scan, requiring manual triggering instead. This malfunction can result in inadequate scan images that require patients to undergo repeat scans and receive additional radiation exposure. The issue affects CT systems distributed nationwide across the United States and Puerto Rico.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Product
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-11
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide Distribution including Puerto Rico
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/fd77aa8e-a3b9-44f3-a195-ed43f2b04e4a