Philips Medical Systems Nederlands recalls Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2

Recall date

November 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1997-2019

FDA classification

Class II

Brand / firm

Philips Medical Systems Nederlands

Sold / distributed

Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2