Reported Jul 26, 2017 · Terminated
Artis zee,x-ray system, angiographic 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 · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Artis zee,x-ray system, angiographic Artis 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. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
- Lot codes and dates
- Serial Numbers
124081124061137662137668137391148001147871154827154847153197131101154035
- Serial Numbers
- Amount recalled
- 97 distributed worldwide, 12 distributed in United States
Where it was sold
Why it was recalled
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
This product could cause temporary or reversible health problems — stop using it.
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