FDA Medical devices recall ·
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity… recall
- Recall number
- Z-2652-2026
- Date
- (initiated June 11, 2026)
- Company / brand
- Philips Medical Systems
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 182
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325
Distribution
US Nationwide Distribution including Puerto Rico
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2652-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.