Philips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue
Philips is recalling 182 Ingenuity CT systems in the US because the clinical scan may not trigger automatically after Bolus Tracking, potentially causing patient rescan and extra radiation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries; the device malfunction poses a risk of inadequate diagnosis and additional radiation, matching the High rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems is recalling 182 Ingenuity CT systems distributed nationwide in the United States, including Puerto Rico. Affected products include the CT5000 Ingenuity Plus, CT5000 Ingenuity Pro, CT5000 Ingenuity Premium, Ingenuity CT Upgrades, Ingenuity CT China, and Ingenuity Core 128 Elite Brazil.
The recall is due to an issue in which the clinical CT scan may not automatically trigger after a Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may also occur. This could make the clinical acquisition inadequate for diagnosis, potentially requiring the patient to be rescanned and exposed to additional radiation.
The FDA has classified this recall as Class II. The recall notice does not report any injuries or deaths and does not provide specific consumer instructions.
The recalled product
- Product
- Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Hazard
- device-malfunction
- radiation-exposure
- inadequate-diagnosis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- FCO72800815
- FCO72800816
Distribution
Distributed nationwide across the United States.
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