Philips Medical Systems Nederlands recalls Azurion lnterventional Fluoroscopic X-ray System, with softw
Recalled Product
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Hazard / Issue
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.
Issued by
FDA
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