BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Palo Alto, California 94304-1038.
FDA device recall Z-3103-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 1252 units
- Distribution
- Worldwide and Nationwide Distribution.
- Date initiated
- 2010-08-11
- Date posted
- 2011-08-31
- Date terminated
- 2011-11-25
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K091492) | Varian Medical Systems, Inc. | 2009-06-18 |