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U.S. Department of Health and Human Services

Class 2 Device Recall Seno Advantage 2.2

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  Class 2 Device Recall Seno Advantage 2.2 see related information
Date Initiated by Firm May 24, 2012
Date Posted October 24, 2012
Recall Status1 Terminated 3 on December 11, 2012
Recall Number Z-0125-2013
Recall Event ID 61612
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

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.
Code Information 000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 000000010002GS 000000010008GS 000000010003GS 00000L3A4391A7 00000L3A8D5CF0 
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 recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
FDA Determined
Cause 2		 Software design
Action Consignees were sent on 5/24/12 a GE Healthcare "Urgent Medical Device Correction" letter dated May 23, 2012. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction. Customers should verify if their workstation is affected. GE Healthcare will correct all affected workstations by providing a software upgrade and Operator Manual update. A GE Healthcare service representative will contact you to arrange this correction. This activity will be performed at no cost to you. 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 12
Distribution Worldwide Distribution -- USA (nationwide) including states of: CA, CT, NY, TX, and MS and countries of TAIWAN, ITALY, CANADA, and BAHRAIN
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS W-400
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