Reported Sep 6, 2017 · Terminated

Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated…

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 zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen 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. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
Lot codes and dates
  • Artis zee ceiling - Serial number

    318 of 318 codes

    • 146996
    • 147100
    • 147233
    • 147049
    • 147678
    • 147763
    • 147803
    • 147885
    • 147084
    • 147190
    • 147189
    • 147573
    • 147889
    • 146993
    • 147909
    • 147833
    • 147847
    • 147888
    • 146965
    • 147273
    • 147761
    • 147030
    • 147239
    • 147783
    • 147891
    • 146988
    • 147677
    • 147882
    • 147562
    • 147608
    • 146980
    • 147036
    • 147581
    • 147857
    • 125001
    • 147604
    • 147371
    • 147899
    • 147129
    • 147210
    • 147923
    • 147760
    • 147636
    • 147081
    • 147267
    • 147047
    • 147679
    • 147667
    • 125002
    • 147685
    • 125011
    • 147042
    • 147630
    • 147835
    • 147208
    • 147247
    • 147096
    • 147912
    • 147515
    • 147236
Amount recalled
986 units in USA

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

  • Nationwide

Why it was recalled

Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.

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

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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

Notice updated Nov 17, 2017 · Data as of Sep 19, 5:25 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.