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

FDA Recall #Z-1997-2019 — Class II — November 30, 2018

Recall #Z-1997-2019 Date: November 30, 2018 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Philips Medical Systems Nederlands — Best, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

229

Distribution

Nationwide

Code Information

software version R1.2

Status

Terminated

Voluntary / Mandated

FDA Mandated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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