FDA-Device2014-04-02Class II
AXIOM Artis Systems Product usage: 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.
Siemens Medical Solutions USA, Inc
Hazard
Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.
Sold states
USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.
Affected count
37
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
AXIOM Artis Systems Product usage: 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1272-2014Don't want to check this manually?
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