FDA-Device2018-08-01Class II
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Siemens Medical Solutions USA, Inc
Hazard
During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
Sold states
The devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.
Affected count
40 in the United States
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2524-2018Don't want to check this manually?
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