Recall Z-3103-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc.
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.
| Date | Aug 31, 2011 (initiated Aug 11, 2010) |
| Status | Terminated |
| Reason | Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 1252 units |
| Distribution | Worldwide and Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091492 | MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Jun 18, 2009 |