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FDANovember 30, 2018device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

philips medical systems nederlandsphilipsphilips medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 — Recall Details · AllClear