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 | K172822 K181830 K200917 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = OWB
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