Reported Jan 19, 2022 · Ongoing

Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System .…

Philips North America LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289

Is this the product you have?

  • 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
Lot codes and dates

25 of 25 products

Products covered by this recall
#BarcodesProduct as published
1459801319471WFS Ad7(X) Option 3P 459801319471
2459801319521WFS Ad7(X) Option 4P+2 459801319521
3459801319361WFS Ad7(X) Option 3P 459801319361
4459801319421WFS Ad7(X) Option 4P+2 459801319421
5459801319481WFS Field Extension Set 3P (ORT) 459801319481
6459801319531WFS Field Extension Set 4P+2 (ORT) 459801319531
7459801319511WFS Field Extension Set 3P 459801319511
8459801319541WFS Field Extension Set 4P+2 459801319541
9459801319371WFS Field Extension Set Mono 459801319371
10459801319431WFS Field Extension Set Biplane 459801319431
11459801319391WFS Field Extension Set Mono (ORT) 459801319391
12459801319441WFS Field Extension Set Biplane (ORT) 459801319441
13459801238241Wireless Footswitch Set 3P 459801238241
14459801238231Wireless Footswitch 3P 459801238231
15459801238261Wireless Footswitch Set 4P+2 459801238261
16459801238251459801238201Wireless Footswitch 4P+2 459801238251 Wireless Footswitch Set JP 459801238201
17459801238191Wireless Footswitch 3P 459801238191
18459801238221Wireless Footswitch Set 4P+2 459801238221
19459801238211Wireless Footswitch 4P+2 459801238211
20459801733051Wireless Footswitch 3P Kit 459801733051
Amount recalled
1971 Total; USA: 681 systems R.O.W.: 1,290 systems

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Philips North America LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.