UroDiagnost — Class II medical device recall Z-2306-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-08-10, distributed nationwide. The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to mo
| Recall number | Z-2306-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-07-19 |
| Classified | 2016-08-01 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2020-10-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CN, CO, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IT, JO, KR, LB, LU, LV, MX, MY, NL, NO, NZ, OM, PH, RS, SA, SE, SG, SI, SK, TH, TR, TW, UA, ZA |
| Quantity | 993 total |
| Reason classes | device malfunction |
| Serial numbers | 708033 |
Product
UroDiagnost; x-ray system. Product Code: 708033
Reason for recall
The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
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-2306-2016. 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.