Recall – X-ray System exposure control software error

Company: Philips Medical Systems Nederlands
Date of Enforcement Report: 8/7/2019
Class II

PRODUCT

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

Recall Number: Z-1997-2019

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.

RECALLING FIRM/MANUFACTURER

Philips Medical Systems Nederlands on 11/30/2018. Voluntary:  FDA Mandated.

VOLUME OF PRODUCT IN COMMERCE
229

DISTRIBUTION

Nationwide

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