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U.S. Department of Health and Human Services

Class 2 Device Recall Allura Xper; Azurion

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  Class 2 Device Recall Allura Xper; Azurion see related information
Date Initiated by Firm October 29, 2021
Date Posted January 10, 2022
Recall Status1 Open3, Classified
Recall Number Z-0476-2022
Recall Event ID 89044
510(K)Number K161563  K200917  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System .
Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722065, 722066, 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228.

Wireless footswitch Models: 459801319471, 459801319521, 459801319361, 459801319421, 459801319481, 459801319531, 459801319511, 459801319541, 459801319371, 459801319431, 459801319391, 459801319441, 459801238241, 459801238231, 459801238261, 459801238251, 459801238201, 459801238191, 459801238221, 459801238211, 459801733051, 459801733061, 459801733071, 459801733081, 459801257861, 459801733091
Code Information Wireless foot switches Models: WFS Ad7(X) Option 3P 459801319471; WFS Ad7(X) Option 4P+2 459801319521; WFS Ad7(X) Option 3P 459801319361; WFS Ad7(X) Option 4P+2 459801319421; WFS Field Extension Set 3P (ORT) 459801319481; WFS Field Extension Set 4P+2 (ORT) 459801319531; WFS Field Extension Set 3P 459801319511; WFS Field Extension Set 4P+2 459801319541; WFS Field Extension Set Mono 459801319371; WFS Field Extension Set Biplane 459801319431; WFS Field Extension Set Mono (ORT) 459801319391; WFS Field Extension Set Biplane (ORT) 459801319441; Wireless Footswitch Set 3P 459801238241; Wireless Footswitch 3P 459801238231; Wireless Footswitch Set 4P+2 459801238261; Wireless Footswitch 4P+2 459801238251 Wireless Footswitch Set JP 459801238201; Wireless Footswitch 3P 459801238191; Wireless Footswitch Set 4P+2 459801238221; Wireless Footswitch 4P+2 459801238211; Wireless Footswitch 3P Kit 459801733051; Wireless Footswitch 3P Kit 459801733061; Wireless Footswitch 4P+2 Kit 459801733071; Wireless Footswitch 4P+2 Kit 459801733081; WFS Base Station 459801257861; WFS Base Station Kil 459801733091.
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall		 Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
FDA Determined
Cause 2		 Device Design
Action Philips notified customers via an Urgent Medical Device Correction letter on October 29th, 2021 via Certified Mail. Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk and actions that should be taken by the user in order to prevent risks for patients or users " Ensure that the wired foot switch is always connected to the system. The wired foot switch is always provided with the Allura Xper and the Azurion systems. " Immediately start using the wired foot switch in case the wireless foot switch loses connection. " Circulate this notice to all users of this device so that they are aware of the issue. " Place this Medical Device Correction with the documentation of the Philips Allura Xper or Azurion system. " Return the attached reply form to Philips to confirm that: the Allura Xper and Azuarion system wired foot switch is connected to the system the users of the system have reviewed and understood this Medical Device Correction. S. The actions planned by Philips IGT Systems to correct the problem You will be contacted by your local Philips representative as soon as this solution is available. If you need any further information or support concerningthis issue, please contact your local Philips representative. Technical Support Line: 1-800-722-9377
Quantity in Commerce 1971 Total; USA: 681 systems R.O.W.: 1,290 systems
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria, Bangladesh, Belgium, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Latvia, Lebanon, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, State of Philippines, Poland, Portugal, R¿union, Romania, RUMANIA, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, UZBEKISTAN, Viet Nam.
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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