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.

Code information: software version R1.2

Distribution pattern: Nationwide