FDA Device recall Z-1997-2019
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 by Philips Medical Systems Nederlands, citing philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1997-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-30 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips Medical Systems Nederlands |
| Distribution | US |
Product
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Reason
Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
Identifiers
| code_info | software version R1.2 |
|---|
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-1997-2019%22
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