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U.S. Department of Health and Human Services

Class 2 Device Recall Azurion lnterventional Fluoroscopic Xray System

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 Class 2 Device Recall Azurion lnterventional Fluoroscopic Xray Systemsee related information
Date Initiated by FirmNovember 30, 2018
Create DateJuly 30, 2019
Recall Status1 Terminated 3 on March 27, 2024
Recall NumberZ-1997-2019
Recall Event ID 83366
510(K)NumberK172822 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductAzurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Code Information software version R1.2
Recalling Firm/
Manufacturer		 Philips Medical Systems Nederlands
Veenpluis 4-6
Best Netherlands
For Additional Information ContactDusty Leppert, CHP
978-659-7892
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce229
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
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