Terminated

GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems.

FDA Recall Z-1063-2012 · Posted 2012-02-20

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeMUE

Date Initiated2011-10-17

Date Terminated2014-03-12

Product Quantity1060

Reason for Recall

GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe 2000D Mammography systems when reviewed on IHE compliant workstations. This issue may impact patient safety.

Firm Action

GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 17, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Contact the Call Center at 800-437-1171 for questions regarding this notice.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, AR, CA,CT, DC,FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WV,and WI and countries of VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, NETHERLANDS, MOROCCO, MEXICO, MALAYSIA, LEBANON, KUWAIT, KOREA, JAPAN, JAM,AICA, ITALY, IRELAND, HUNGARY, HONG KONG, HONDURAS, GREECE, GERMANY, GEORGIA, FRANCE, EGYPT, DOMINICAN REPUBLIC, COLUMBIA, CHINA, CHILE, CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, and ARGENTINA.

Official Source

View FDA Recall →

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