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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 Posted January 30, 2013
Recall Status1 Terminated 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
262-513-4122
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 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 = KPQ and Original Applicant = GE HEALTHCARE
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