GE ADVANTAGE SIM MD versions 5.x…

Date posted by the FDA

March 2, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 Advantage Sim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR, PET or SPECT studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph

Reason

GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combination with specified other functions of the AdvantageSim application on Advantage Workstation. These inconsistencies may affect patient safety. Other AdvantageSim functions are not affected.

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MA, MI, MN, MS,MO, NT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, POLAND, PAKISTAN, NOWAY, NIGERIA, NETHERLANDS, MEXICO, MALAYSIA, LITHUANIA, LATVIA, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, ECUADOR, DOMINICA REPUBLIC, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BRAZIL BELGIUM, AUSTRIA, AUSTRALIA.

Quantity

1531

Codes and lots

Serial Number 00000132364GE1 00000009851GE7 00000184342GE4 00000186390GE1 00000184339GE0 00000186389GE3 00000184341GE6 00000184340GE8 00000184338GE2 00000063115GE0 00000067040GE6 00000069353GE1 00000098315VP5 00000044657GE5 00000099698VP3 00000028881GE1 00000030810HP6 00000028878GE7 00000025475GE5 00000009900GE2 00000009850GE9 00000002678GE1 00000068373GE0 00000112962GE6 00000006609GE2 00000006605GE0 00000041805GE3 00000041804GE6 00000046030GE3 00000008134GE9 00000140656GE0 00000152559GE1 00000152558GE3 00000123784GE1 00000030995HP5 00000035199GE9 00000112965GE9 00000098362VP7 00000063886GE6 00000098721VP4 00000018769GE0 00000109868GE0 00000124937GE4 00000030846HP0 00000025485GE4 00000018779GE9 00000152560GE9 00000041800GE4 00000113881GE7 00000018781GE5 00000056503GE6 00000061414DP9 00000010204GE6 00000061413DP1 00000018673AW4 00000085514GE8 00000127013GE1 00000030793HP4 00000030807HP2 00000001442GE3 00000085513GE0 00000076520GE6 00000142885GE3 263 00000028877GE9 00000108671GE9 00000101181VP6 00000106448GE4 00000106867GE5 00000118326GE8 00000192700GE3 00000001511GE5 00000082780GE8 00000001446GE4 00000005679GE6 00000005492GE4 00000018671AW8 00000099859VP1 00000138886GE7 00000080674GE5 00000017037VE3 00000052577GE4 00000090481GE3 00000006416GE2 00000157089GE4 00000007463GE3 00000006418GE8 00000007465GE8 00000090488GE8 00000022887VE4 00000098603GE4 00000010197GE2 00000051673GE2 00000003616GE0 00000165784GE0 00000005563GE2 00000025484GE7 00000116935GE8 00000068390GE4 00000068391GE2 00000000ASM009 00000159393GE8 00000098598GE6 00000076531GE3 00000001451GE4 00000165782GE4 00000152556GE7 00000008137GE2 00000100000VP9 00000098596GE0 00000098600GE0 00000194611GE0 00000127667GE4 00000152562GE5 00000025472GE2 00000001448GE0 00000114870GE9 00000114871GE7 00000124938GE2 00000138887GE5 00000162306GE5 00000037513GE9 00000018760AW9 00000030922HP9 00000098609GE1 00000165783GE2 00000056504GE4 00000174250GE1 00000064212GE4 00000106872GE5 00000019273VE2 00000051667GE4 00000073484GE8 00000112968GE3 00000134785GE5 00000068374GE8 00000102304VP3 00000028895GE1 00000127665GE8 00000006611GE8 00000069358GE0 00000099606VP6 00000030906HP2 00000098604GE2 00000025481GE3 00000102315VP9 00000100838GE2 00000174248GE5 00000111715GE9 00000114868GE3 00000102229VP2 00000030982HP3 00000100867VP1 00000001449GE8 00000025486GE2 00000018783GE1 00000100836GE6 00000073486GE3 00000073485GE5 00000021235GE7 00000144923GE0 00000073490GE5 00000001444GE9 00000106870GE9 00000028884GE5 00000121719GE9 00000028886GE0 00000028876GE1 00000018778GE1 00000145027GE9 00000106450GE0 00000031035HP9 00000106451GE8 00000138881GE8 00000028894GE4 00000098296VP7 00000182511GE6 00000068376GE3 00000098592GE9 00000069361GE4 00000009893GE9 00000061425GE5 00000145023GE8 00000090486GE2 00000163709GE9 00000079708GE4 00000069348GE1 00000174247GE7 00000073491GE3 00000073492GE1 00000001520GE6 00000019279VE9 00000190302GE0 00000010190GE7 00000186396GE8 00000041013GE4 00000082787GE3 00000096084GE9 00000080675GE2…

Recall started

Nov. 24, 2010

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 23, 2010. The letter was addressed to Hospital Administrators / Risk mangers, Oncology Department Managers / Radiation Oncologists, & Radiation Physicists / Dosimetrists / Therapists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For any questions or concerns regarding this recall, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative.

Recall number

Z-1473-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1473-2011. The agency record governs; check it and the company before acting.