BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Palo Alto, California 94304-1038. Used to plan radiotherapy treatments for patients with malignant or benign diseases. In addition, the module is specifically indicated for planning proton treatment of neoplasms of the eye.
This recall has been terminated (originally issued August 31, 2011).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- August 11, 2010
- Posted
- August 31, 2011
- Terminated
- November 25, 2011
- Recall Number
- Z-3103-2011
- Quantity
- 1252 units
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.
Distribution
Worldwide and Nationwide Distribution.
Lot / Code Info
Versions 8.2, 8.5, 8.6 and 8.9
Root Cause
Software design
Action Taken
Varian Medical Systems, Inc. sent a "Medical Device Recall" letter dated August 05, 2010 to all affected customers. The letter included description of product affected and problem. Customers were advised to review template files to ensure that there are no characters immediately after the string in the customized dose quality parameters. Device users were requested to return a response form. For information on this recall contact Varian Technical Support at (800) 360-7909.