IQon Spectral CT — Class II medical device recall Z-1316-2026
Ongoing recall by Philips North America Llc, reported 2026-02-18, distributed nationwide. As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing
| Recall number | Z-1316-2026 |
|---|---|
| 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 | 2026-01-07 |
| Classified | 2026-02-06 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BH, BR, CH, CL, CN, CR, CZ, DE, DK, EC, EG, ES, FR, GB, HK, HR, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, LT, MX, NL, NO, NZ, PA, PH, PL, PT, RS, SA, SG, SV, TH, TW, VN, ZA |
| Quantity | 52 units |
| UPC / GTIN / UDI-DI | 00884838059542 |
| Serial numbers | 60128, 60129, 60130, 60132, 60133, 60134, 60136, 60137, 60138, 60139, 60141, 60142, 60143, 60144, 60145, 60146, 60147, 60148, 60149, 60150, 60151, 60152, 60153, 60154, 60155 and 27 more |
| Model numbers | 00884838059542, 728332 |
Product
IQon Spectral CT; Product Code (REF): 728332;
Reason for recall
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
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-1316-2026. 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.