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U.S. Department of Health and Human Services

Class 2 Device Recall Azurion

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  Class 2 Device Recall Azurion see related information
Date Initiated by Firm July 19, 2023
Date Posted September 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-2403-2023
Recall Event ID 92855
510(K)Number K200917  K181830  K172822  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Azurion
Code Information Azurion series
Recalling Firm/
Manufacturer		 Philips Medical Systems Nederland B.V.
High Tech Campus 36
Eindhoven Netherlands
For Additional Information Contact Dusty Leppert, CHP
978-228-0190
Manufacturer Reason
for Recall		 A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide actions that should be taken by the customer/user in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. (Philips reference 2023-IGT-BST-011).
Quantity in Commerce 5432 systems in total
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV
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