Home / Recalls / Medical Devices
Siemens Medical Solutions USA, Inc recalls ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Recalled August 1, 2018 · FDA recall Z-2524-2018 · Siemens Medical Solutions USA
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 ). · FDA Class II
Units
40 in the United States
Sold at
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.
Description
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 ).
Product
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →