Reported Feb 21, 2018 · Terminated

Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one…

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?

  • Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
Lot codes and dates
    • Serial # 82044
    • 82105
    • 82070
    • 82054
    • 82040
    • 82038
    • 82065 82108
    • 82010
    • 82039
    • 82109 82102 82066
Amount recalled
207 worldwide (13 distributed in US)

Where it was sold

Why it was recalled

The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen

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 Aug 21, 2018 · 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.