AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
FDA Recall Z-0754-2013 · Posted 2013-01-30
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeKPQ
Date Initiated2012-05-24
Date Terminated2014-01-16
Product Quantity65
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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