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.
FDA Recall Z-3103-2011 · Posted 2011-08-31
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Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-08-11
Date Terminated2011-11-25
Product Quantity1252 units
Reason for Recall
Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide and Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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