FDA-Device2018-08-01Class II
AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Siemens Medical Solutions USA, Inc
Hazard
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
Sold states
HI , IL, MI, NC, NY, VA, WI
Affected count
6 units US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2525-2018Don't want to check this manually?
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