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U.S. Department of Health and Human Services

Class 2 Device Recall GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM

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 Class 2 Device Recall GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM see related information
Date Posted October 26, 2011
Recall Status1 Terminated on October 16, 2012
Recall Number Z-0114-2012
Recall Event ID 59326
PMA Number P990066 
Product Classification Full field digital, system, x-ray, mammographic - Product Code MUE
Product GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL).

The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.
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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer 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.
FDA Determined
Cause 2
Software design
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.
Quantity in Commerce 2113
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MUE and Original Applicant = GE Healthcare
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