Reported Mar 22, 2017 · Terminated

Axiom Artis fluoroscopic x-ray system

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 fluoroscopic x-ray system
Lot codes and dates
  • Device Model4787813
  • Serial Numbers

    2,158 of 2,158 codes

    • 15260
    • 20888
    • 1104
    • 20249
    • 15197
    • 10252
    • 20019
    • 20613
    • 15508
    • 10234
    • 20425
    • 21143
    • 22191
    • 20124
    • 20369
    • 20681
    • 22147
    • 21346
    • 1260
    • 10127
    • 10107
    • 10100
    • 15238
    • 20128
    • 21959
    • 21966
    • 21217
    • 1204
    • 21419
    • 20721
    • 21235
    • 22085
    • 1129
    • 20627
    • 20637
    • 1294
    • 1295
    • 20240
    • 21439
    • 20715
    • 1444
    • 20983
    • 22439
    • 20171
    • 1085
    • 21885
    • 1119
    • 17109
    • 15692
    • 1065
    • 17227
    • 17223
    • 21622
    • 10008
    • 10094
    • 20432
    • 21722
    • 1801
    • 22421
    • 10275
Amount recalled
2,158 units distributed in US and 6,139 worldwide

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.

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 Jan 14, 2019 · Data as of Sep 19, 6:15 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.