Philips North America Llc: Medical Device Recall in 2022 - (Recall #: Z-0476-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 29, 2021

Date Posted: January 19, 2022

Recall Number: Z-0476-2022

Event ID: 89044

Reason for Recall:

Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

Status: Ongoing

Product Quantity: 1971 Total; USA: 681 systems R.O.W.: 1,290 systems

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated