Reported Apr 2, 2014 · Terminated

AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single 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 · 51 Valley Stream Pkwy · Malvern, PA · 19355

Is this the product you have?

  • AXIOM Artis Systems Product usageArtis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
Lot codes and dates
    • Model nos. 7412807
    • 7727717
    • 7728392
  • with serial numbers35020, 34999,35098
    • 35113
    • 35042
    • 35061
    • 35064
    • 35073
    • 35014
    • 35069
    • 35053
    • 35055
    • 35056
    • 35054
    • 35008
    • 35057
    • 35044
    • 35018
    • 35097
    • 35108
    • 35046
    • 35048
    • 35050
    • 35045
    • 35004
    • 35019
    • 46004
    • 46005
    • 40000
    • 40009
    • 40011
    • 40006
    • 40007
    • 40010
    • 44016
    • 44005
    • 44011
Amount recalled
37

This recall covers 2 products

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

Where it was sold

Why it was recalled

Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.

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 Dec 30, 2014 · Data as of Sep 19, 5:22 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.