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 device recall Z-0754-2013 · posted 2013-01-30 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

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

Status

Terminated

Product code

KPQ

Quantity affected

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, INDI

Date initiated

2012-05-24

Date posted

2013-01-30

Date terminated

2014-01-16

Location

Waukesha, WI

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