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Siemens Medical Solutions USA, Inc recalls Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Recalled July 13, 2022 · FDA recall Z-1342-2022 · Siemens Medical Solutions USA
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. · FDA Class II
Units
195 worldwide, 88 US
Sold at
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.
Description
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.
Product
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →