Company:Varian Medical Systems Oncology Systems.
Date of Enforcement Report 10/21/2009
Class:ll
PRODUCT
Clinac with Version 7.x Software. Model Numbers: H14, H27 and H29. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy. Recall # Z-1729-2009
REASON
Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated May 29, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,933 units
DISTRIBUTION
Nationwide and Internationally
