Spectral CT 7500: Software Version 5 — Class II medical device recall Z-1055-2024
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-1055-2024 |
|---|---|
| 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 |
| Reason classes | labeling, software |
| UPC / GTIN / UDI-DI | 00884838101111 |
| Serial numbers | 10013, 10014, 10015, 10016, 10017, 10018, 10019, 10020, 10021, 10022, 10023, 10024, 10025, 10027, 10031, 10032, 10033, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10042 and 185 more |
| Model numbers | 728333, 728340 |
Product
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
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-1055-2024. 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.