Company:Varian Medical Systems Oncology Systems.
Date of Enforcement Report 11/25/2009
Class:ll
PRODUCT
VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Recall # Z-0133-2010
REASON
Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on September 15, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION
Nationwide and Internationally
