Reported Mar 7, 2018 · Terminated

Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.

Siemens Medical Solutions USA, 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: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

  • Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory
  • Model Numbers
    • 4787797
    • 4787805
    • and 4787813
Lot codes and dates
  • Serial Numbers

    142 of 142 codes

    • 10006
    • 10010
    • 10017
    • 10025
    • 10044
    • 10050
    • 10051
    • 10055
    • 1044
    • 1078
    • 1081
    • 15000
    • 15001
    • 15018
    • 15021
    • 15032
    • 15044
    • 15047
    • 15056
    • 15058
    • 15060
    • 15076
    • 15088
    • 15091
    • 15105
    • 15114
    • 15116
    • 15131
    • 15144
    • 15148
    • 15149
    • 17002
    • 17004
    • 17007
    • 17011
    • 17032
    • 17050
    • 17061
    • 17062
    • 17074
    • 17078
    • 17084
    • 17142
    • 20001
    • 20002
    • 20005
    • 20009
    • 20015
    • 20024
    • 20030
    • 21004
    • 21006
    • 21017
    • 21022
    • 21028
    • 21033
    • 21039
    • 21047
    • 21052
    • 21054
Amount recalled
142

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was recalled

The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.

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 Mar 9, 2020 · Data as of Sep 19, 4:47 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.