Terminated

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.

FDA Recall Z-1086-2015 · Posted 2015-02-10

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeKPS

Date Initiated2012-10-23

Date Terminated2016-12-23

Product Quantity719 systems (global)

Reason for Recall

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

Firm Action

Consignees were not notified of this issue.

Root Cause

Component design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041166SIEMENS ENHANCED IMAGING SYSTEMSiemens Medical Solutions USA, Inc. · 2004-05-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.