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U.S. Department of Health and Human Services

Class 2 Device Recall Seno Advantage 2.2 workstations with software version 22_01 and 22_02

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 Class 2 Recall
Seno Advantage 2.2 workstations with software version 22_01 and 22_02
see related information
Date Posted June 02, 2010
Recall Status1 Terminated on December 18, 2011
Recall Number Z-1747-2010
Recall Event ID 55387
Premarket Notification
510(K) Number
K033400 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
Code Information SERIAL NUMBER 000000A9316002 000000A9316008 000000F9314002 000000F9314013 000000Q9309007 000000Q9309012 000000Q9309013 000000Q9309015 000000W9321002 000000W9321004 000000A9316004 000000A9316014 000000A9316015 000000A9345002 000000A9345003 000000A9345007 000000A9345009 000000A9345019 000000A9345020 000000F9314005 000000F9314010 000000F9314014 000000Q9309002 000000Q9309003 000000Q9309006 000000W9321003 000000P9300003 000000A9316012 000000P9300002 000000F9314011 000000W9321001 000000W9321007 000000W9321008 000000W9321010 000000W9321006 000000A9316006 000000A9316003 000000A9316005 000000P9300001 000000Q9309010 000000Q9309014 000000A9345015 000000Q9309005 000000A9316011 000000A9345012 000000A9345013 000000A9345014 000000A9345016 000000A9345018 000000F9314004 000000Q9309001 00000D10011003 00000D10011006 000000A9316001 000000F9314008 000000F9314012 000000P9300004 000000W9321009 000000A9316010 000000F9314007 000000W9321005 000000A9316007 000000A9316009 000000F9314015 000000F9314006 000000Q9356005 00000ZA9260001 000000Q9309008 000000A9345001 000000A9345017 000000F9314001 000000Q9309004 000000Q9356001
Recalling Firm/
Manufacturer
Ge Healthcare, Llc
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. When using the Print Image or Print Screen feature on SenoAdvantage 2.2, the Scale factor annotation printed on hard copy images is inaccurate. Secondary Capture (SCPT) images displayed on the screen and Secondary Capture hard copy images may a
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated February 8, 2010 to customers. The letter described the Safety Issue, Affected product details, Safety Instructions to prevent further inaccurate scale factor annotation, Product Correction and Contact Information. GE Healthcare will correct all affected workstations by providing a software upgrade and an updated Operator Manual. The GE service representative will contact customer to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800-437-1171, Japan: -0120-055-919. For other countries, please contact your local GE Healthcare Service Representative.
Quantity in Commerce 73 devices
Distribution Worldwide distribution: USA including states of CA, FL, GA, MD, NJ, NM, NY, NC, OK, TX and countries of THAILAND, TAIWAN, SWEDEN SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, PAKISTAN, MEXICO, JAPAN, ITALY,GREECE, FRANCE, COLOMBIA, CHILE, CANADA, BELGIUM, and BAHRAIN.
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.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS W-400
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