PHILIPS MEDICAL SYSTEMS: Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Co
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- US Nationwide Distribution including Puerto Rico
- Recall initiated
- 2026-06-11
- Code info
- FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325
- Product quantity
- 182
- Voluntary mandated
- FDA Mandated
- City
- Cambridge
- State
- MA
- Country
- United States
- Event id
- 99352
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