Reported Apr 24, 2019 · Terminated

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

Philips Medical Systems Nederlands

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 Nederlands · Veenpluis 4-6 · Best, N/A · N/A

Is this the product you have?

  • Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector
  • Product Codes708037, 708038 Product The Allura Xper FD Series are intended
  • for use on human patients to performVascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures
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
7209 total

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

Why it was recalled

Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 14, 2020 · Data as of Sep 19, 6:56 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.