ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of…

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• ARTIS Pheno-Interventional
• Fluoroscopic X-Ray System Model Number10849000 -
• Product UsageAXIOM Artis 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 family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis

Lot codes and dates

• All serial numbers

Amount recalled

96 US

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

• Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device…
• Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device…
• Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device…
• Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device…
• Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device…
• Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system…

Where it was sold

• Nationwide

Why it was recalled

Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements

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