Company: Varian Medical Systems Inc.
Date of Enforcement Report 1/19/2011
Class ll:
PRODUCT
4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc., Palo Alto, CA Intended use: The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Recall # Z-0891-2011
REASON
Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated October 16, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3629
DISTRIBUTION
Nationwide, Australia, Asia, China, Japan, Latin American, New Zealand , North America, South East Asia
