| ||Class 2 Recall|
||January 30, 2013
||Terminated on January 16, 2014
|Recall Event ID
System, Simulation, Radiation Therapy - Product Code KPQ
||AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
||Mfg Lot or Serial #
|GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
|It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
|DESIGN: Software Design
||GE Healthcare sent an "Urgent Medical Device Correction" letter dated May 11,2012, to all consignees on May 24, 2012. The letter identified the product, the problem, and the action to be taken by the consignee. The letter addressed the Safety Issue, Safety Instructions, Affected Product,, Product Correction and Contact Information. GE indicated that a GE Healthcare service representative would contact they would correct all affected systems by providing a software upgrade at no cost to the consignee. For questions customers were instructed to call one of the following numers:
Japan 0120 - 055 - 919
For questions regarding this recall call 262-513-4122.
|Quantity in Commerce
||Worldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA, NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN.
|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 = KPQ and Original Applicant = GE HEALTHCARE