Spectral CT and Spectral CT Plus — Class II medical device recall Z-0583-2025
Ongoing recall by Philips North America Llc, reported 2024-12-11, distributed nationwide. Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a
| Recall number | Z-0583-2025 |
|---|---|
| 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 | 2024-11-16 |
| Classified | 2024-12-03 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CN, CZ, DE, DK, EC, ES, FR, GB, HK, IL, IT, JO, JP, KR, MY, NL, NO, NZ, PA, PL, PT, SG, TH, TW, VN |
| Quantity | 301 units |
| Reason classes | 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 274 more |
| Model 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 274 more |
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Reason for recall
Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.
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-0583-2025. 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.