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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Advantage Workstations

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 Class 2 Recall
GE Healthcare Advantage Workstations
see related information
Date Posted November 28, 2007
Recall Status1 Open
Recall Number Z-0265-2008
Recall Event ID 45514
Premarket Notification
510(K) Numbers
K020483  K052995 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2,GE Healthcare, Waukesha, WI. 53188
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Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Aortic Length over-estimated: incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should NOT BE USED.
FDA Determined
Cause 2
DESIGN: Software Design
Action An Urgent Safety Notice to customers dated 9/10/07, was issued by the recalling firm informing them of the device defect, safety issues, warnings on future uses and promised new software updates to be installed by GE representatives, free of charge, beginning Nov. 2007.
Quantity in Commerce 2,518
Distribution Worldwide Distribution - USA including states of AK, AL, AR, AZ, CA, CO, CT, CU, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Guam, and countries of Canada, Mexico. Argentina, Brazil, Chile, Colombia, Dominican Republic, Ecuador, Australia, China, Honk Kong, Indonesia, Japan, Korea, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Albania, Austria, Azerbaijan, Bosnia, Belgium, Belarus, Switzerland, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Guadeloupe, Greece, Hungary , Ireland, Israel, Italy, Kuwait, Lebanon, Morocco, Netherlands, Norway, French Polynesia, Poland, Portugal, Russian Federation, Saudi Arabia, Sweden, Slovenia, Tunisia, Turkey, and South Africa.
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 HEALTHCARE
510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS
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