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,
Check against the official notice below — it lists the full affected range.
Philips North America LLC is recalling wireless foot switches used with Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray Systems due to connection issues that can interrupt fluoroscopy and exposure during procedures. The recall affects approximately 1,971 wireless foot switch systems worldwide, including 681 systems in the USA and 1,290 systems in other countries including Canada, Australia, and numerous European, Asian, and Middle Eastern nations. The affected products include multiple wireless foot switch models and field extension sets with various model numbers ranging from 459801238191 to 459801733091.
The recall notice does not specify a remedy or actions that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
Reason for recall: Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure 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, Quantity: 1971 Total; USA: 681 systems R.O.W.: 1,290 systems Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.