Philips Medical Systems: System, X-ray, Tomography, Computed
Recall Summary Philips is recalling several Ingenuity CT scanner models distributed nationwide because the system may fail to automatically start a clinical CT scan after a Bolus Tracking scan, requiring manual triggering instead. This malfunction could result in inadequate scan images that require patients to undergo repeat scans and receive additional radiation exposure. The recall affects CT scanning equipment used in medical facilities across all U.S. states and territories.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Product
- Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
- 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/1887ff7a-ab7e-47f5-b64a-c653cc1f838e