Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-0476-2022 · Posted 2022-01-10

Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2021-10-29
Product Quantity1971 Total; USA: 681 systems R.O.W.: 1,290 systems

Reason for Recall

Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

Firm 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

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020-05-01K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016-07-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑