Philips CT systems labeled as the following: 1 — Class II medical device recall Z-2597-2025
Ongoing recall by Philips North America Llc, reported 2025-10-01, distributed nationwide. The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball
| Recall number | Z-2597-2025 |
|---|---|
| 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 | 2025-08-13 |
| Classified | 2025-09-19 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CZ, DE, DK, EG, ES, FR, GB, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, LB, LV, MX, NL, NO, PE, PH, PL, PT, QA, RO, SE, TH, TW, VN |
| Quantity | 33 units |
| UPC / GTIN / UDI-DI | 00884838059450, 00884838095168 |
| Serial numbers | 7179, 7238, 7271, 7273, 7418, 7467, 750003, 750019, 75035, 75045, 75111, 75119, 75132, 760019, 760057, 760058, 760075, 76023, 76054, 7608, 76135, 76147, 76171, 7618, 76230 and 8 more |
| Model numbers | 728242, 728243, 728244 |
Product
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
Reason for recall
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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-2597-2025. 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.