FDA Device recall Z-1492-2020
UroDiagnost Eleva, system code 708033
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of UroDiagnost Eleva, system code 708033 by Philips North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1492-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-30 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
UroDiagnost Eleva, system code 708033
Reason
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.
Identifiers
| code_info | Serial numbers 64 48 2 60 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1492-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.