Company:Varian Medical Systems
Date of Enforcement Report 6/29/2011
Class ll:
PRODUCT
Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Recall # Z-2220-2011
REASON
An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated April 4, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5,288 units
DISTRIBUTION
Nationwide and Internationally
