Spectral CT on Rails: Software Version 5 — Class II medical device recall Z-1054-2024
Ongoing recall by PHILIPS MEDICAL SYSTEMS, reported 2024-02-14, distributed nationwide. A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent i
| Recall number | Z-1054-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS, Cambridge, MA, United States |
| Recall initiated | 2023-12-13 |
| Classified | 2024-02-08 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CN, CZ, DE, DK, ES, GB, IL, IT, JP, KR, MY, NL, NO, PA, PT, SG, TH, TW |
| Quantity | 1 |
| Reason classes | labeling, software |
| UPC / GTIN / UDI-DI | 00884838103627 |
| Serial numbers | 1005 |
| Model numbers | 728334 |
Product
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Reason for recall
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
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-1054-2024. 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.