FDA-Device2015-02-18Class II
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.
Siemens Medical Solutions USA, Inc.
Hazard
There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
Sold states
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.
Affected count
719 systems (global)
Manufactured in
2501 Barrington Rd, N/A, Hoffman Estates, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1086-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief