Siemens Symbia S Series system recalled over fire hazard

Recall date

July 31, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Siemens Medical Solutions USA, Inc. recalls Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine…

Recall number

Z-2435-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.