Reported May 22, 2019 · Terminated
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: 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 Q (material 108482801084828110848282) -
- Product UsageAXIOM 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 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 and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
- Lot codes and dates
- Serial Number
71 of 71 codes
103302103279103285103286103277103295103310103293109569109502109592109523109583109512109496109542109589109552109598109500109504109505109526109565109536109520109501109507109567109541109515109551109518109538109531109532109543109503109497109527109560109564109558109524109525109591121471121467121501121445121459121490121461121491121455121504121457121460121493121487
- Serial Number
- Amount recalled
- 459 (116 US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
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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