Recall Z-1718-2009
GE Medical Systems, LLC · initiated February 2, 2009
Product
AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.
Codes / lots: Serial Numbers: 00000118329GE2, 00000142883GE8, 00000142882GE0, 00000111103GE8, 00000051589GE0, 00000108666GE9, 00000127664GE1, 00000068379GE7, 00000073497GE0, 00000142884GE6, 00000051586GE6, 00000113886GE6, 00000080150GE6, 00000124934GE1, 00000073489GE7, 00000098605GE9, 00000106869GE1, 00000090499GE5, 00000090489GE6, 00000076519GE8, 00000080672GE9, 00000080481GE5, 00000134781GE4, 00000134782GE2, 00000132360GE9, 00000134789GE7, 00000069359GE8, 00000069362GE2, 00000138883GE4, 00000051665GE8, 00000051666GE6, 00000100844GE0, 00000061315GE8, 00000090495GE3, 00000076526GE3, 00000051583GE3, 00000051584GE1, 00000052631GE9, 00000109919GE1, 00000114863GE4, 00000109867GE2, 00000081296GE6, 00000108668GE5, 00000142879GE6, 00000068377GE1, 00000142878GE8, 00000138880GE0, 00000140659GE4, 00000112963GE4, 00000069347GE3, 00000134783GE0, 00000138888GE3, 00000118327GE6, 00000121720GE7, 00000109866GE4, 00000090496GE1, 00000081289GE1, 00000073483GE0, 00000106871GE7, 00000076518GE0, 00000068372GE2, 00000082782GE4, 00000108670GE1, 00000069349GE9, 00000123789GE0, 00000076517GE2, 00000124941GE6, 00000100849GE9, 00000063726GE4, 00000098601GE8, 00000096093GE0, 00000051671GE6, 00000090492GE0…
Reason for recall
It was reported by a customer site that when using Advantage Sim 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: Software design
Action taken
GE Healthcare issued an "Urgent Medical Device Correction" letter dated March 11, 2009. The letter was addressed to AdvantageSim Customers, Hospital Administrators/ Risk Mangers and Oncology Department Mangers. The letter addressed the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. For further questions, contact GE Healthcare at 1-800-437-1171 (US), 0120-055-919 (Japan) and for other countries, contact your local GE Healthcare sales or field service representative.
Details
- Recall number
- Z-1718-2009
- Initiated
- February 2, 2009
- Posted by FDA
- August 17, 2009
- Terminated
- December 10, 2011
- Product code
- KPQ – System, Simulation, Radiation Therapy
- Quantity
- 687 units (351 US / 336 OUS)
- Distribution
- Worldwide Distribution -- Including states of AL, AZ, CA, CO, CT, FL, GA, DC, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS,MO, MT,NE, NH, NJ, NM, NY, NC, ND, OH, OK PR, PA, SC, SD, TN, TX, UT, VA, WA and WI and AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, NETHERLANDS…
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI