Siemens Medical Solutions USA, Inc. recalls The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions,…

Recall date

October 23, 2012

Source

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

Recall number

Z-1086-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, and WY), and the countries of AUSTRALIA , AUS…

Why it was recalled

There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.

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

What was recalled

The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.