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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 06, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on September 21, 2004
Recall NumberZ-0582-04
Recall Event ID 28300
Product Classification System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
ProductEPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.
Code Information Serial numbers (Domestic units): 724 215 765 210 212 217 218 214 767 213 743 706708 784 727 795 710 899 702 898 820 219 750 757 894 799 852 821 216 788 202 873 786 896 797 826 709 889 848
FEI Number 3000206172
Recalling Firm/
Manufacturer		 Varian Medical Systems
700 Harris St
Suite 109
Charlottesville VA 22903-4584
For Additional Information ContactRachel Plesko
434-977-8495
Manufacturer Reason
for Recall		Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.
FDA Determined
Cause 2		Other
ActionThe recalling firm notified end users by letters flagged 'Urgent Medical Device Correction' on 2/2/04. The notification reminds users to verify the decay factor before patient treatment. The letter also advises that instrument software be be updated commencing March 2004.
Quantity in Commerce203
DistributionProduct was distributed to end users in the United States and internationally.
Total Product Life CycleTPLC 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.
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