FDA-Device2018-03-28Class II
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM 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.
Siemens Medical Solutions USA, Inc
Hazard
Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Sold states
US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.
Affected count
22
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1150-2018Don't want to check this manually?
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