Company: Varian Medical Systems
Date of Enforcement Report: 3/10/04
Class: II
PRODUCT
EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader. Recall # Z-0582-04.
REASON
Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy
CODE
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.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Charlottesville, VA, by letters on February 2, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
203.
DISTRIBUTION
Nationwide and Internationally.
