Spectral CT — Class II medical device recall Z-2034-2025
Ongoing recall by Philips North America Llc, reported 2025-07-02, distributed in AZ, CA, CO, FL, GA, HI, IN, KY…. Devices with affected software may experience two unintended motion issues that may lead to contact between th
| Recall number | Z-2034-2025 |
|---|---|
| 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 | 2025-05-29 |
| Classified | 2025-06-26 |
| Reported by FDA | 2025-07-02 |
| Distributed | AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV |
| Countries outside the US | AT, AU, BE, CH, CN, CZ, DE, DK, EC, ES, FR, GB, HK, IE, IL, IN, IQ, IR, IT, JO, JP, KR, LT, MY, NL, NO, NZ, PA, PH, PL, PT, SG, TH, TW, VN |
| Quantity | 370 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 268 more |
| Model numbers | 728333 |
Product
Spectral CT. Computed tomography X-ray system.
Reason for recall
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
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-2034-2025. 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.