Varian Medical Systems EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.
Brand
Varian Medical Systems
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Varian Medical Systems is recalling EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufacture due to Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachythera. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.
Recommended Action
Per FDA guidance
The 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026