Company: Varian Medical Systems
Date of Enforcement Report:8/23/2006
Class:ll
PRODUCT
a) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst
and vers.-row, part number GM11005400, for the GammaMed model 12i
radionuclide applicator system, Recall # Z-1398-06;
b) GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst
and vers.-row , part number GM11005400, for the GammaMed model 12it
radionuclide applicator system, Recall # Z-1399-06
REASON
Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.
CODE
a) GammaMed ”12i” serial numbers: GM00797 GM00795 GM00896 GM00852
GM00873 GM00708 GM0F278 GM00710 GM00848 GM00899 GM00820
GM00757 GM00821 GM00889 GM00727 GM00706 GM0710 GM00898
GM00743 GM00826 GM00784 GM00786;
b) GammaMed ”12it” serial numbers: GM00213 GM00218 GM00219TB GM00215
GM00202 GM00216 GM00217 GM00212 GM00219TA GM00219 GM00210
GM00214 GM0213
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, CharlottesvilleVA, by letter on 4/17/06 and continuing through 5/1/06.
Manufacturer: Varian Medical Systems, Haan, Germany. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide
