Spectral CT on Rails — Class II medical device recall Z-1324-2025
Ongoing recall by Philips Medical Systems Nederland B.V., reported 2025-03-19, distributed in MN. Multiple problems identified with the software version leading to various scanning and image issues, and unint
| Recall number | Z-1324-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems Nederland B.V., Best, Netherlands |
| Recall initiated | 2025-02-28 |
| Classified | 2025-03-12 |
| Reported by FDA | 2025-03-19 |
| Distributed | MN |
| Quantity | 1 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838103627 |
| Serial numbers | 1005 |
| Model numbers | 728334 |
Product
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Reason for recall
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
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-1324-2025. 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.