Company: Varian Oncology
Date of Enforcement Report 8/6/2008
Class:ll

PRODUCT
High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator, Recall # Z-1459-2008

REASON
Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient..

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on January 29, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3 systems

DISTRIBUTION
Nationwide