FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-3103-2011
- Recalling firm
- Varian Medical Systems, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-08-11
- Posted
- 2011-08-31
- Terminated
- 2011-11-25
- 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.
- Lot, serial or model codes
- Versions 8.2, 8.5, 8.6 and 8.9
- 510(k) numbers
- ["K091492"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 3000206172
- Firm city
- Charlottesville
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28