Terminated

GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS system generates digital mammographic images, which can be used for screening and diagnosis of breast cancer. The Senographe DS is intended to be used in the same clinical applications as traditional mammographic film/screen systems.

FDA Recall Z-0115-2012 · Posted 2011-10-26

Recalling FirmGE Healthcare, LLC

Recall StatusTerminated

Product CodeMUE

Date Initiated2011-09-22

Date Terminated2012-10-16

Product Quantity1344

Reason for Recall

GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS and Essential 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 September 21, 2011 to all affected customers. The letter describes the products, problem, and actions to be taken by the customers. The letter provides safety instructions and advises customers to complete and return a Customer Reply Form via fax to +33(0)1 30 70 39 30. A GE Healthcare service representative will contact customers if the updated software version is required. Contact the Call Center at 800-437-1171.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-USA (nationwide) including Puerto Rico and Washington, D.C. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA,GERMANY, GREECE, GUADELOUPE, GUYANA, HONDURAS, HONG KONG, HUNGARY, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, REPUBLIC OF KOREA, RUSSIAN FEDERATION SAINT PIERRE AND MIQUELON, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE FORMER YUGOSLAV REPUBLIC OF MECEDONIA, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VENEZUELA.

Official Source

View FDA Recall →

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