Recall Z-1997-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Medical Systems Nederlands
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
| Date | Nov 30, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On November 30, 2018, Philips initiated a software update in the field. Among other performance improvements , this software update included the correction for poor image quality under very specific situations. |
| Quantity | 229 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172822 | Azurion series R1.2 Philips Medical Systems Nederland B.V., Nov 22, 2017 |