FDA-Device2018-03-07Class II
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Siemens Medical Solutions USA, Inc
Hazard
The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
Sold states
Distributed in XX states: Ak, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, the District of Columbia, Guam, and Puerto Rico.
Affected count
510
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0710-2018Don't want to check this manually?
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