High FDA (Devices)·Z-0476-2022·Announced 2022-01-19

Philips wireless footswitches for Allura Xper and Azurion X-ray systems recalled for connection issues

Philips wireless footswitches used with Allura Xper and Azurion X-ray systems may experience connection issues that interrupt fluoroscopic imaging during patient procedures. The recall affects 1,971 systems distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving connection issues that may interrupt critical fluoroscopic imaging during patient procedures. No hospitalizations or injuries have been reported, but the device malfunction presents a risk to clinical operations.

Plain-English summary

Philips North America is recalling wireless footswitches used with Allura Xper and Azurion Interventional Fluoroscopic X-ray Systems. The affected footswitches control imaging functions during medical interventional procedures. Multiple models of wireless footswitches are involved in this recall.

The recalled footswitches may experience wireless connection issues that interrupt fluoroscopic imaging during patient procedures. Connection failures could disrupt the imaging controls needed during interventional radiology procedures.

The recall affects 1,971 systems: 681 in the United States and 1,290 outside the US, distributed to healthcare facilities in over 45 countries worldwide.

Healthcare facilities using affected Allura Xper or Azurion X-ray systems should contact Philips North America for corrective actions and replacement options.

The recalled product

Product: 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, 72
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging / X-ray Equipment
Hazard: connection-failure
equipment-malfunction
imaging-interruption

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips North America Llc

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Same hazard · connection failure