FDA-Device2013-09-04Class II

Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

Siemens Medical Solutions USA, Inc
Hazard

The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.

Sold states
US Distribution including the states of PA, NJ, DC, VA, MD and DE.
Affected count
178
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2108-2013

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