FDA · Medical device recall

GE Senographe Essential Full Field Mammography System (Seno… and 1 more product

Oct. 26, 2011

Date posted by the FDA: Oct. 26, 2011
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: 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.
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.

2 products in this recall

GE Senographe Essential Full Field Mammography System (Seno Essential)…

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.
Quantity: 2113
Codes and lots: 00000547934BU0 00000550439BU4 00000550440BU2 00000545752BU8 00000546928BU3 00000541751BU4 00000515362BU2 00000549414BU1 00000545533BU2 00000538081BU1 00000538079BU5 00000541521BU1 00000549617BU9 00000551111BU8 00000544650BU5 00000547807BU8 00000542784BU4 00000542774BU5 00000548878BU8 00000547936BU5 00000538083BU7 00000540208BU6 00000541513BU8 00000544653BU9 00000538077BU9 00000541526BU0 00000545530BU8 00000542777BU8 00000518220BU9 00000541523BU7 00000544655BU4 00000546328BU6 00000550992BU2 00000546932BU5 00000547230BU3 00000550179BU6 00000548885BU3 00000541522BU9 00000546590BU1 00000546587BU7 00000541511BU2 00000538082BU9 00000541525BU2 00000546592BU7 00000550990BU6 00000518217BU5 00000542782BU8 00000547931BU6 00000542778BU6 00000546931BU7 00000541519BU5 00000541528BU6 00000550182BU0 00000546326BU0 00000541527BU8 00000540211BU0 00000542783BU6 00000548881BU2 00000545751BU0 00000541512BU0 00000546594BU3 00000547811BU0 00000541515BU3 00000540213BU6 00000547809BU4 00000547930BU8 00000546930BU9 00000543377BU6 00000547806BU0 00000549612BU0 00000546522BU4 00000544657BU0 00000547935BU7 00000551110BU0 00000518222BU5 00000543373BU5 00000515908BU2 00000551471BU6 00000543380BU0 00000538075BU3 00000547372BU3 00000544652BU1 00000518221BU7 00000518214BU2 00000518216BU7 00000517330BU7 00000544656BU2 00000549406BU7 00000546593BU5 00000550184BU6 00000515605BU4 00000545748BU6 00000550177BU0 00000546325BU2 00000542781BU0 00000518219BU1 00000545747BU8 00000546591BU9 00000543379BU2 00000546595BU0 00000543374BU3 00000543375BU0 00000540214BU4 00000542779BU4 00000543372BU7 00000541520BU3 00000542785BU1 00000599501BU4 00000515907BU4 00000546929BU1 00000542776BU0 00000548879BU6 00000550178BU8 00000545749BU4 00000541514BU6 00000540207BU8 00000545536BU5 00000549411BU7 00000548883BU8 00000549409BU1 00000547374BU9 00000515910BU8 00000544658BU8 00000550991BU4 00000542780BU2 00000547216BU2 00000540916BU4 00000540209BU4 00000550185BU3 00000547376BU4 00000514379BU7 00000515909BU0 00000544651BU3 00000541517BU9 00000549614BU6 00000547375BU6 00000546324BU5 00000546329BU4 00000545535BU7 00000545529BU0 00000546327BU8 00000547373BU1 00000542775BU2 00000549412BU5 000000MIO11094 00000543378BU4 00000550867BU6 00000546589BU3 00000547808BU6 00000549615BU3 00000538037BU3 00000541516BU1 00000545537BU3 00000545753BU6 00000549567BU6 00000550560BU7 00000547932BU4 00000541524BU5 00000545750BU2 00000540210BU2 00000549613BU8 00000550181BU2 00000550869BU2 00000538036BU5 00000550183BU8 00000550865BU0 00000513305BU3 00000550180BU4 00000548882BU0 00000549413BU3 00000518223BU3 00000549407BU5 00000518218BU3 00000543376BU8 00000540215BU1 00000549410BU9 00000544654BU7 00000547805BU2 00000541518BU7 00000546596BU8 00000547804BU5 00000552471BU5 00000538074BU6 UNK51448160001 00000551112BU6 00000551470BU8 00000547812BU8 00000523004BU0 UNK51448160000 00000538080BU3 00000551472BU4 00000601239BU7 00000540212BU8 00000538078BU7 00000545756BU9 00000541530BU2 00000545755BU1 00000601543BU2 00000540206BU0 00000550278BU6…
Recall started: Sept. 22, 2011
Device type: Full Field Digital, System, X-Ray, Mammographic
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0114-2012

GE Senographe DS Full Field Digital Essential Mammography System…

Product: 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.
Quantity: 1344
Codes and lots: 00000446698BU3 00000458422BU3 00000436651BU4 00000442506BU2 00000435660BU6 00000442065BU9 00000436731BU4 00000446249BU5 00000443044BU3 00000454054BU8 00000444143BU2 00000454692BU5 00000435092BU2 00000440404BU2 00000444147BU3 00000442509BU6 00000438832BU8 00000442508BU8 00000446703BU1 00000446705BU6 00000440044BU6 00000446248BU7 00000446247BU9 00000434692BU0 00000454062BU1 00000436443BU6 00000462884BU8 00000452594BU5 00000454063BU9 00000440047BU9 00000444823BU9 00000462885BU5 00000441222BU7 00000441444BU7 00000440046BU1 00000447730BU3 00000460034BU2 00000451652BU2 000000D1S06124 00000458278BU9 00000541528BU6 00000435662BU2 00000438576BU1 00000439241BU1 00000461119BU0 00000452071BU4 00000449095BU9 00000446243BU8 00000451648BU0 00000461118BU2 00000462887BU1 00000461120BU8 00000461116BU6 00000433752BU3 00000467566BU6 00000467565BU8 00000440397BU8 00000439565BU3 00000439569BU5 00000432817BU5 00000441403BU3 00000440403BU4 00000445722BU2 00000446242BU0 00000440395BU2 00000440045BU3 00000439563BU8 00000439567BU9 00000447733BU7 00000444825BU4 00000460037BU5 00000461114BU1 00000451653BU0 00000434694BU6 00000441609BU5 00000451651BU4 00000045718BU0 00000430540BU5 00000436653BU0 00000435311BU6 00000440399BU4 00000440398BU6 00000468378BU5 00000446246BU1 00000447737BU8 00000460038BU3 00000443045BU0 00000449094BU2 00000447738BU6 00000434695BU3 00000438577BU9 00000442066BU7 00000446704BU9 00000445720BU6 00000434693BU8 00000458418BU1 00000430484BU6 00000446250BU3 00000461115BU8 00000464402BU7 00000452601BU8 00000439564BU6 00000462879BU8 00000461121BU6 00000435661BU4 00000436728BU0 00000444821BU3 00000446699BU1 00000451649BU8 00000452068BU0 00000452595BU2 00000044625BU9 00000444820BU5 00000452076BU3 00000444144BU0 00000464403BU5 00000443043BU5 00000441611BU1 00000442067BU5 00000437869BU1 00000439560BU4 00000452077BU1 00000439568BU7 00000446241BU2 00000464401BU9 00000464405BU0 00000432429BU9 00000439561BU2 00000441225BU0 00000460031BU8 00000446251BU1 00000443047BU6 00000043894BU6 00000438946BU6 00000443046BU8 00000429865BU9 00000447739BU4 00000436652BU2 00000439562BU0 00000454057BU1 00000464400BU1 00000436730BU6 00000452075BU5 00000436732BU2 00000452072BU2 00000462888BU9 00000440400BU0 00000441612BU9 00000460035BU9 00000452598BU6 00000468379BU3 00000430829BU2 00000447472BU2 00000438368BU3 00000444819BU7 00000454696BU6 00000454056BU3 00000449096BU7 00000446696BU7 00000445721BU4 00000461122BU4 00000451650BU6 00000454694BU1 00000462881BU4 00000454693BU3 00000461113BU3 00000452596BU0 00000441221BU9 00000426075BU8 00000449091BU8 00000435312BU4 00000462883BU0 00000442068BU3 00000446701BU5 00000458421BU5 00000444816BU3 00000452070BU6 00000452602BU6 00000444146BU5 00000445717BU2 00000445723BU0 00000444818BU9 00000447471BU4 00000442505BU4 00000449090BU0 00000451644BU9 00000454055BU5 00000452597BU8 00000452599BU4 00000452073BU0 00000460036BU7 00000458277BU1 00000452600BU0 00000454695BU8 00000462882BU2 00000462886BU3 00000460039BU1 00000447735BU2 00000464397BU9 00000447469BU8…
Recall started: Sept. 22, 2011
Device type: Full Field Digital, System, X-Ray, Mammographic
Root cause (FDA): Software design
What the company told customers: 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.
Recall number: Z-0115-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0114-2012, Z-0115-2012. The agency record governs; check it and the company before acting.

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