{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190369", "product_res_number": "Z-0476-2022", "event_date_initiated": "2021-10-29", "event_date_posted": "2022-01-10", "recall_status": "Open, Classified", "res_event_number": "89044", "product_code": "OWB", "k_numbers": [ "K161563", "K200917" ], "product_description": "Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System .\nModel 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.\n\nWireless 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_info": "Wireless foot switches Models:\nWFS Ad7(X) Option 3P\t459801319471;\nWFS Ad7(X) Option 4P+2\t459801319521;\nWFS Ad7(X) Option 3P\t459801319361;\nWFS Ad7(X) Option 4P+2\t459801319421;\nWFS Field Extension Set 3P (ORT)\t459801319481;\nWFS Field Extension Set 4P+2 (ORT)\t459801319531;\nWFS Field Extension Set 3P\t459801319511;\nWFS Field Extension Set 4P+2\t459801319541;\nWFS Field Extension Set Mono\t459801319371;\nWFS Field Extension Set Biplane\t459801319431;\nWFS Field Extension Set Mono (ORT)\t459801319391;\nWFS Field Extension Set Biplane (ORT)\t459801319441;\nWireless Footswitch Set 3P\t459801238241;\nWireless Footswitch 3P\t459801238231;\nWireless Footswitch Set 4P+2\t459801238261;\nWireless Footswitch 4P+2\t459801238251\nWireless Footswitch Set JP\t459801238201;\nWireless Footswitch 3P\t459801238191;\nWireless Footswitch Set 4P+2\t459801238221;\nWireless Footswitch 4P+2\t459801238211;\nWireless Footswitch 3P Kit\t459801733051;\nWireless Footswitch 3P Kit\t459801733061;\nWireless Footswitch 4P+2 Kit\t459801733071;\nWireless Footswitch 4P+2 Kit\t459801733081;\nWFS Base Station\t459801257861;\nWFS Base Station Kil\t459801733091.", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "reason_for_recall": "Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure", "root_cause_description": "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 \nactions that should be taken by the user in order to prevent risks for patients or users\n\" Ensure that the wired foot switch is always connected to the system. The wired foot switch is\nalways provided with the Allura Xper and the Azurion systems.\n\" Immediately start using the wired foot switch in case the wireless foot switch loses connection.\n\" Circulate this notice to all users of this device so that they are aware of the issue.\n\" Place this Medical Device Correction with the documentation of the Philips Allura Xper or Azurion system.\n\" Return the attached reply form to Philips to confirm that:\nthe Allura Xper and Azuarion system wired foot switch is connected to the system\nthe users of the system have reviewed and understood this Medical Device Correction.\nS. The actions planned by Philips IGT Systems to correct the problem\nYou will be contacted by your local Philips representative as soon as this solution is available.\nIf you need any further information or support concerningthis issue, please contact your local Philips representative. Technical Support Line: 1-800-722-9377", "product_quantity": "1971 Total;\tUSA: 681 systems\tR.O.W.: 1,290 systems", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria, \nBangladesh, 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, \nLatvia, Lebanon, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, \nPalestine, State of Philippines, Poland, Portugal, R¿union, Romania, RUMANIA, \nRussian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, \nSpain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, UZBEKISTAN, Viet Nam.", "openfda": { "k_number": [ "K133580", "K022069", "K982993", "K240099", "K222080", "K254173", "K093066", "K221922", "K252735", "K002016", "K123508", 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