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Terminated

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

FDA Recall Z-1997-2019 · Posted None

Recalling FirmPhilips Medical Systems Nederlands
Recall StatusTerminated
Product CodeOWB
Date Initiated2018-11-30
Date Terminated2024-03-27
Product Quantity229

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.

Firm Action

On November 30, 2018, Philips initiated a software update in the field. Among other performance improvements , this software update included the correction for poor image quality under very specific situations.

Root Cause

Device Design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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