Spectral CT 7500 — Class II medical device recall Z-0725-2024
Ongoing recall by Philips North America Llc, reported 2024-01-24, distributed nationwide. Multiple software issues that affect device functionality.
| Recall number | Z-0725-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2023-11-30 |
| Classified | 2024-01-12 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CN, CZ, DE, DK, ES, FR, GB, IL, IT, JP, KR, MY, NL, NO, PA, PT, TH |
| Quantity | 197 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838101111, 00884838111103 |
| Serial numbers | 10013, 10014, 10015, 10016, 10017, 10018, 10019, 10020, 10021, 10022, 10023, 10024, 10025, 10031, 10032, 10033, 10034, 10035, 10036, 10038, 10039, 10040, 10041, 10042, 10043 and 172 more |
| Model numbers | 728333, 728340 |
Product
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Reason for recall
Multiple software issues that affect device functionality.
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-0725-2024. 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.