Reported Jun 15, 2022 · Ongoing

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

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 biplane -angiography systems developed for single and biplane diagnostic imaging
  • and interventional procedures SMN11327600
Lot codes and dates
  • UDI-DI04056869063317
  • Serial Number
    • 180062
    • 180054
    • 180019
    • 180065
    • 180056
    • 180057
    • 180041
    • 180317
    • 180034
    • 180072
    • 180060
    • 180070
    • 180048
    • 180083
    • 180315
    • 180080
    • 180301
    • 180305
    • 180067
    • 180330
    • 180040
    • 180333
    • 180029
    • 180336
    • 180316
    • 180084
    • 180334
    • 180018
    • 180046
    • 180047
    • 180335
    • 180085
    • 180035
    • 180081
    • 180331
    • 180021
    • 180321
    • 180309
    • 180323
    • 180329
    • 180043
    • 180049
    • 180077
    • 180086
    • 180053
    • 180055
    • 180015
    • 180014
    • 180066
    • 180082
    • 180037
Amount recalled
51 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?

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

Data as of Sep 19, 6:55 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.