FDA-Device2022-07-13Class II
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Siemens Medical Solutions USA, Inc
Hazard
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
Sold states
Domestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Japan, Kazakhstan, Netherlands, New Zealand, Norway, Oman, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.
Affected count
195 worldwide, 88 US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1342-2022Don't want to check this manually?
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