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
722001722002722003722005722006722008722010722011722012722013722014722015722019722020722022722023722024722025722026722027722028722029722033722034722035722036722038722039722058722059722065722066722063722064722067722068722078722079722221722222722223722224722225722226722227722228
- Wireless footswitch Models
459801319471459801319521459801319361459801319421459801319481459801319531459801319511459801319541459801319371459801319431459801319391459801319441459801238241459801238231459801238261459801238251459801238201459801238191459801238221459801238211459801733051459801733061459801733071459801733081459801257861459801733091
- Lot codes and dates
25 of 25 products
Products covered by this recall # Barcodes Product as published 1 459801319471WFS Ad7(X) Option 3P 459801319471 2 459801319521WFS Ad7(X) Option 4P+2 459801319521 3 459801319361WFS Ad7(X) Option 3P 459801319361 4 459801319421WFS Ad7(X) Option 4P+2 459801319421 5 459801319481WFS Field Extension Set 3P (ORT) 459801319481 6 459801319531WFS Field Extension Set 4P+2 (ORT) 459801319531 7 459801319511WFS Field Extension Set 3P 459801319511 8 459801319541WFS Field Extension Set 4P+2 459801319541 9 459801319371WFS Field Extension Set Mono 459801319371 10 459801319431WFS Field Extension Set Biplane 459801319431 11 459801319391WFS Field Extension Set Mono (ORT) 459801319391 12 459801319441WFS Field Extension Set Biplane (ORT) 459801319441 13 459801238241Wireless Footswitch Set 3P 459801238241 14 459801238231Wireless Footswitch 3P 459801238231 15 459801238261Wireless Footswitch Set 4P+2 459801238261 16 459801238251459801238201Wireless Footswitch 4P+2 459801238251 Wireless Footswitch Set JP 459801238201 17 459801238191Wireless Footswitch 3P 459801238191 18 459801238221Wireless Footswitch Set 4P+2 459801238221 19 459801238211Wireless Footswitch 4P+2 459801238211 20 459801733051Wireless 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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