Recall Z-0476-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America Llc
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, 722
| Date | Jan 10, 2022 (initiated Oct 29, 2021) |
| Status | Open, Classified |
| Reason | Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure |
| Root cause | 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 connec |
| Quantity | 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, Ital |
| FDA record | Open on fda.gov |