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

Recalled February 18, 2015 · FDA recall Z-1087-2015 · Siemens Medical Solutions USA

Hazard

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

Units

1,075 systems (global)

Sold at

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 , AUSTRIA, BANGLADESH , BELGIUM , BRAZIL , BULGARIA , CANADA , CHILE , CHINA , COLOMBIA , CROATIA , CZECH REPUBLIC , DENMARK , ECUADOR , EGYPT , FINLAND , FRANCE , GERMANY , GREECE , HONG KONG , HUNGARY , INDIA , INDONESIA , IRAN , IRELAND , ISRAEL , ITALY , JAPAN , KUWAIT , LATVIA , LITHUANIA , MEXICO , MOROCCO , NETHERLANDS , NEW ZEALAND , NORWAY , PERU , PHILIPPINES , POLAND , PORTUGAL , QATAR , ROMANIA , RUSSIA , SAUDI ARABIA , SINGAPORE , SLOVAKIA , SOUTH AFRICA , SPAIN , SWEDEN , SWITZERLAND , TAIWAIN , THAILAND , TUNISIA , TURKEY , UNITED ARAB EMIRATES, UNITED KINGDOM , and VENEZUELA.

Description

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

Product

The Siemens Symbia T 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.

Manufacturer(s)

Siemens Medical Solutions USA, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →