UroDiagnost Eleva — Class II medical device recall Z-1492-2020
Terminated recall by Philips North America, LLC, reported 2020-03-25, distributed nationwide. A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a sh
| Recall number | Z-1492-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2019-12-30 |
| Classified | 2020-03-13 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2022-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
| Reason classes | device malfunction |
Product
UroDiagnost Eleva, system code 708033
Reason for recall
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
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-1492-2020. 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.