Z-1412-2010

Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0...

Name: Z-1412-2010 Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0...
Creator: Varian Medical Systems Oncology Systems
Published: 2009-12-09
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2009-12-09 / Terminated / root cause: software

FDA source

Varian Medical Systems Oncology Systems began a recall of Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds... on 2009-12-09. The reason FDA records is "Potential for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the 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-1412-2010
Status: Terminated
Initiated: 2009-12-09
Posted: 2010-04-20
Terminated: 2012-02-24
Recalling firm: Varian Medical Systems, Inc.
Product: Varian Medical Systems, Eclipse Treatment Planning System, with v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x). For radiation therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Potential for misdelivery of treatment-- When preparing a treatment plan involving a split, the device may calculate excessive or insufficient monitor units for the treatment plan.
Root cause tag: software
FDA root cause: Software design
Action: Recall initiated on 12/09/2009. Varian issued a notification letter to its consignees, including a description and corrective action step. The firm is in the process of preparing a software fix for the issue.
Quantity in commerce: 3177 unit
Distribution: Nationwide distribution and Mexico.
Product codes and lots: v client versions 7.3 (build 7.3.10), 8.0 (builds 7.5.x), 8.1 (builds 8.1.x) and 8.5( builds 8.2.x), with serial numbers starting with H48.

Product code MUJ

K073020Class IIEclipse Treatment Planning SystemVarian Medical Systems, Inc. / cleared 2007-12-19

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)