medical Class II Updated 2019-08-07

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

Distribution: Nationwide (United States)
Lot/Code Info: software version R1.2
View official government recall

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