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Siemens Medical Solutions USA, Inc. recalls Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed t
Recalled August 26, 2015 · FDA recall Z-2437-2015 · Siemens Medical Solutions USA
Hazard
Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly. · FDA Class II
Units
185
Sold at
Worldwide Distribution - USA including AL, AK, 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, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Internationally to Algeria, Argentina , Australia , Austria , Bangladesh , Belgium , Brazil , Bulgaria , Canada , Chile , China, Colombia , Costa Rica , Croatia , Czech Republic , Denmark , Ecuador , Egypt , Estonia, Finland , France , Germany , Hong Kong , Hungary , Iceland , India , Indonesia , Iran , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Korea, Kuwait , Latvia , Libya , Lithuania , Luxembourg , Malaysia , Mexico , Morocco , Myanmar , Netherlands , New Zealand , Norway , Oman , Pakistan , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia, Saudi Arabia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania, Thailand , Tunisia , Turkey , United Arab Emirates , Ukraine , United Kingdom , Venezuela , Vietnam
Description
Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.
Product
Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →