Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000… — Class II medical device recall Z-2652-2026
Ongoing recall by PHILIPS MEDICAL SYSTEMS, reported 2026-08-05, distributed nationwide. The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered
| Recall number | Z-2652-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | PHILIPS MEDICAL SYSTEMS, Cambridge, MA, United States |
| Recall initiated | 2026-06-11 |
| Classified | 2026-07-27 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 182 |
| UPC / GTIN / UDI-DI | 00884838059498, 00884838059504, 00884838059511, 00884838059863, 00884838098701 |
Product
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2652-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.