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U.S. Department of Health and Human Services

Class 2 Device Recall GammaMed software

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  Class 2 Device Recall GammaMed software see related information
Date Initiated by Firm May 01, 2006
Date Posted August 10, 2006
Recall Status1 Terminated 3 on December 05, 2006
Recall Number Z-1398-06
Recall Event ID 35717
510(K)Number K891131  
Product Classification radiation treatment system - Product Code JAQ
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Varian Medical Systems
700 Harris Street
Suite 109
Charlottesville VA 22903-4584
For Additional Information Contact Brachytherapy Technical Support
800-360-7909
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
Action The recalling firm notified healthcare practitioners using the medical device by letter on 4/17/06 and continuing through 5/1/06. The notification was flagged as a 'Medical Device Recall' and instructed users to adjust system parameters in the autoexec.bat file. The notification further recommended using the identified treatment plans and that manual input should be used for QA purposes only.
Quantity in Commerce 22 units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAQ and Original Applicant = MICK RADIO-NUCLEAR INSTRUMENTS, INC.
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