Company: Varian Medical Systems, Inc.
Date of Enforcement Report 6/22/2011
Class ll:

PRODUCT
Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, For use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions. Recall # Z-2200-2011.

REASON
A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral offset error.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated March 30, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
598 units

DISTRIBUTION
Nationwide and Internationally