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U.S. Department of Health and Human Services

Class 2 Device Recall AdvantageSim MD

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  Class 2 Device Recall AdvantageSim MD see related information
Date Initiated by Firm May 24, 2012
Date Posting Updated January 30, 2013
Recall Status1 Terminated 3 on January 16, 2014
Recall Number Z-0754-2013
Recall Event ID 61611
510(K)Number K052345  
Product Classification System, simulation, radiation therapy - Product Code KPQ
Product AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
Code Information Mfg Lot or Serial #, 00000L022E05AE, 00000139595HP3, 000000010003GS, 000000410012GS, 000000210016GS, 000000210013GS, 00000138998HP0, 00000139435HP2, 000000410010GS, 000000410009GS, 000000210005GS, 000000210011GS, 000000210012GS, 000000210015GS, 00000138991HP5, 000000210014GS, 000000310005GS, 00000139574HP8, 00000139604HP3, 00000L026CC222, 000000210010GS, 000000010004GS, 000000410011GS, 000000410007GS, 000000210023GS, 000000210025GS, 000000210026GS, 000000210022GS, 000000210024GS, 000000410005GS, 000000410006GS, 000000310003GS, 000000310002GS, 000000210006GS, 000000210007GS, 000000210003GS, 000000410004GS, 000000310001GS, 000000010001GS, 000000210030GS, 000000210008GS, 000000410016GS, 000000P8059001, 000000210027GS, 000000410008GS, 000000410001GS, 000000210017GS, 000000210019GS, 000000210021GS, 000000210020GS, 000000310008GS, 000000210018GS, 000000410014GS, 000000210029GS, 000000210004GS, 000000210001GS, 000000210009GS, 000000410003GS, 000000410013GS, 000000210028GS, 000000410017GS, 000000410015GS, 000000310007GS, 000000310006GS, 000000010005GS
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
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.
FDA Determined
Cause 2
Software design
Action 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: USA 800-437-1171 Japan 0120 - 055 - 919 For questions regarding this recall call 262-513-4122.
Quantity in Commerce 65
Distribution 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 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 = KPQ and Original Applicant = GE HEALTHCARE
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