Philips CT systems labeled as the following: 1 — Class II medical device recall Z-2601-2025
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-2601-2025 |
|---|---|
| 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 | 81 units |
| UPC / GTIN / UDI-DI | 00884838059542 |
| Serial numbers | 395003, 395005, 60001, 60003, 60007, 60010, 60012, 60013, 60019, 60027, 60030, 60031, 60036, 60041, 60053, 60054, 60055, 60058, 60079, 60123, 60129, 60145, 60152, 860008, 860009 and 56 more |
| Model numbers | 728332 |
Product
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
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-2601-2025. 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.