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U.S. Department of Health and Human Services

Class 2 Device Recall Azurion R2.1

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 Class 2 Device Recall Azurion R2.1see related information
Date Initiated by FirmFebruary 02, 2022
Create DateApril 05, 2022
Recall Status1 Terminated 3 on November 05, 2024
Recall NumberZ-0737-2022
Recall Event ID 89750
510(K)NumberK200917 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductPhilips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Code Information Azurion R2.1
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips Healthcare
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactDusty Leppert
978-228-0190
Manufacturer Reason
for Recall		Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated February 2, 2022. Philips will schedule an appointment with customers to install the software update. Philips will correct the affected systems at no cost to customers with a software upgrade. For information contact your local Philips representative: 1-800-722-9377.
Quantity in Commerce42 Systems
DistributionUS Nationwide distribution.
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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