Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed… — Class II medical device recall Z-2315-2021
Terminated recall by Philips North America Llc, reported 2021-08-25, distributed nationwide. When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) softwar
| Recall number | Z-2315-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-06-08 |
| Classified | 2021-08-18 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2023-08-10 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838059498, 00884838059504 |
| Model numbers | 40004, 728321, 728321/728323, 728332, CT5000 |
Product
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Reason for recall
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
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-2315-2021. 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.