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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips North America Llc
- Reason for Recall:
- Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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 Codes/Lot Numbers:
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 Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0476-2022
Related Recalls
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Philips North America
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
IntelliVue MP90. Product Number: M8010A.
Philips North America
Potential issue where the IntelliVue monitors did not alarm.
IntelliVue MP30. Product Number: M8002A.
Philips North America
Potential issue where the IntelliVue monitors did not alarm.