Reported Mar 31, 2021 · Terminated

Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and…

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

Is this the product you have?

  • Interventional Fluoroscopic
  • X-Ray System - Product Usagedeveloped for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
Lot codes and dates
  • ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700
Amount recalled
29 systems

Where it was sold

Why it was recalled

Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.

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 11, 2021 · Data as of Sep 19, 6:22 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.