Reported Apr 22, 2015 · Terminated

Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane…

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 Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Lot codes and dates
  • Model Number of device
    • 10848280
    • 10848281
    • 10848282
    • 10848283
    • 10848353
    • 10848354
    • 10848355
  • with serial numbers

    139 of 139 codes

    • 109033
    • 123026
    • 121061
    • 121089
    • 121094
    • 109080
    • 109074
    • 121006
    • 121013
    • 121040
    • 109119
    • 111005
    • 109016
    • 121062
    • 109118
    • 111002
    • 121082
    • 121011
    • 121039
    • 123008
    • 109066
    • 109067
    • 109068
    • 121053
    • 121054
    • 117001
    • 117023
    • 123003
    • 123011
    • 103030
    • 109084
    • 121014
    • 121051
    • 109011
    • 109096
    • 121004
    • 117021
    • 121018
    • 121036
    • 123013
    • 123014
    • 117029
    • 117006
    • 121012
    • 121049
    • 103013
    • 109102
    • 121078
    • 109015
    • 109009
    • 121019
    • 109057
    • 121010
    • 117034
    • 109108
    • 103008
    • 109103
    • 121081
    • 109038
    • 109040
Amount recalled
139

Where it was sold

  • Nationwide

Why it was recalled

potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.

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 6, 2015 · Data as of Sep 19, 5:30 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.