Reported Apr 6, 2016 · Terminated

Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips…

Philips Medical Systems, Inc.

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 Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector
  • Product Codes708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This
  • includes the following general areasDigestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system
  • VariousArthrograms, Myelograms, Facet joint injections, Discography, Sialography
Lot codes and dates
  • Foot Switches
    • 452270000141 Footswitch CV 3p 4m
    • 452270000151 Footswitch MD 3p 6m
    • 452270000142 Footswitch CV 3p 4m
    • 452270000381 Footswitch CV 3p 8m
    • 452270000382 Footswitch CV 3p 8m
    • 459800076001 Footswitch CV 4p+2 4m
    • 459800076021 Footswitch CV 4p+2 8m
    • 459800415571 Wireless Footswitch 4p+2
    • 459800415581 Wireless footswitch set 4p+2
    • 459800415531 Wireless Footswitch 3P
    • 459800415561 Wireless footswitch set 3P
Amount recalled
168

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

Loss of key image functionality due to a bent pedal of the Footswitch.

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.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 26, 2019 · Data as of Sep 19, 6:02 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.