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 floor- Serial number

    116 of 116 codes

    • 137623
    • 137165
    • 137282
    • 137618
    • 137226
    • 136513
    • 136562
    • 137118
    • 137103
    • 137461
    • 137510
    • 137193
    • 137479
    • 137425
    • 137540
    • 137532
    • 137314
    • 137295
    • 137582
    • 137592
    • 136568
    • 137075
    • 137130
    • 137188
    • 137131
    • 137146
    • 136607
    • 136579
    • 137388
    • 137470
    • 124007
    • 124015
    • 137347
    • 137638
    • 137389
    • 137595
    • 137245
    • 137620
    • 137335
    • 137617
    • 137607
    • 136500
    • 136515
    • 137369
    • 137569
    • 136479
    • 137119
    • 124051
    • 136488
    • 136550
    • 136450
    • 136408
    • 136547
    • 136508
    • 136517
    • 124039
    • 137360
    • 137311
    • 137320
    • 136586
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.

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

Notice updated Nov 17, 2017 · Data as of Sep 19, 6:02 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.