| ||Class 2 Recall|
Seno Advantage 2.2 workstations with software version 22_01 and 22_02
||June 02, 2010
||Terminated on December 18, 2011
|Recall Event ID
System, Image Processing, Radiological - Product Code LLZ
||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.
|Ge Healthcare, Llc
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
|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
|DESIGN: Software Design
||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
||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)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS W-400