Z-3103-2011

BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Palo Alto, California...

Name: Z-3103-2011 BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Palo Alto, California...
Creator: Varian Medical Systems, Inc.
Published: 2010-08-11
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2010-08-11 / Terminated / root cause: software

FDA source

Varian Medical Systems, Inc. began a recall of 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... on 2010-08-11. The reason FDA records is "Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3103-2011
Status: Terminated
Initiated: 2010-08-11
Posted: 2011-08-31
Terminated: 2011-11-25
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.
Root cause tag: software
FDA 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 in commerce: 1252 units
Distribution: Worldwide and Nationwide Distribution.
Product codes and lots: Versions 8.2, 8.5, 8.6 and 8.9

Product code MUJ

K091492Class IIModification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. / cleared 2009-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)