Reported Jun 15, 2022 · Ongoing

Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures…

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 icono floor-angiography systems developed for single and biplane diagnostic imaging
  • and interventional procedures SMN11327700
Lot codes and dates
  • UDI-DI04056869149325
  • Serial Number
    • 170026
    • 170305
    • 170307
    • 170309
    • 170310
    • 170023
    • 170304
    • 170025
    • 170051
    • 170312
    • 170027
    • 170303
    • 170053
Amount recalled
13 units

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

if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

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

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 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.