Philips Brilliance CT Big Bore — Class II medical device recall Z-1660-2025
Ongoing recall by Philips North America Llc, reported 2025-04-30, distributed nationwide. Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with
| Recall number | Z-1660-2025 |
|---|---|
| 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 | 2025-04-01 |
| Classified | 2025-04-23 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CZ, DE, DZ, EE, ES, FR, GB, HK, HN, ID, IL, IN, IQ, IR, IT, KR, LB, LU, MA, MX, NL, NO, NZ, PA, PH, PL, PT, SA, SE, SG, SI, TH, TW, ZA |
| Quantity | 630 units |
| UPC / GTIN / UDI-DI | 00845225003036, 00845225003043, 00845225003050, 00884838059450, 00884838095168, 00884838098725, 00884838101142 |
| Serial numbers | 20001, 20002, 20003, 20004, 20005, 20006, 20007, 20008, 20009, 20010, 20011, 20012, 20013, 20014, 20015, 20016, 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025 and 475 more |
| Model numbers | 728242, 728243, 728244 |
Product
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Reason for recall
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
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-1660-2025. 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.