Company: Varian Medical Systems Oncology Systems
Date of Enforcement Report 10/8/2008
Class:ll
PRODUCT
Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments, Recall # Z-2308-2008
REASON
Software anomaly in which swapping IDs of planning fields can produce inconsistencies between dose matrix and field parameters.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on June 11, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
907 units
DISTRIBUTION
Nationwide and Internationally