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.
This recall has been terminated (originally issued August 17, 2009).
- Company
- Ge Medical Systems, Llc
- Recall Initiated
- February 2, 2009
- Posted
- August 17, 2009
- Terminated
- December 10, 2011
- Recall Number
- Z-1718-2009
- Quantity
- 687 units (351 US / 336 OUS)
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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.
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, POLAND, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TOKELAU, TURKEY, UNITED ARAB EMIRATES and the UNITED KINGDOM.
Lot / Code Info
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, 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00000054196AW1, 00000080485GE6, 00000080486GE4, 00000080671GE1, 00000100835GE8 and 00000053651AW6.
Root 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.