Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2435-2015)

Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.

Class II

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.

Model number 8717741.

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

Voluntary: Firm initiated