FDA-Device2018-03-28Class II
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include cardiac angiography, neuro-angiography, general angiography, rotational angiography; multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extr
Siemens Medical Solutions USA, Inc
Hazard
Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
Sold states
US Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and WA.
Affected count
16
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include cardiac angiography, neuro-angiography, general angiography, rotational angiography; multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1148-2018Don't want to check this manually?
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