FDA-Device2014-04-09Class II

Artis Zee Angiographic x-ray systems.

Siemens Medical Solutions USA, Inc
Hazard

An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.

Sold states
MN, WI, PA, MI, AL, OH, NC, AR, and NJ.
Affected count
9
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Artis Zee Angiographic x-ray systems.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1309-2014

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