Z-2231-2009

Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation...

Name: Z-2231-2009 Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation...
Creator: Varian Medical Systems Oncology Systems
Published: 2009-07-17
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2009-07-17 / Terminated / root cause: software

FDA source

Varian Medical Systems Oncology Systems began a recall of Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system on 2009-07-17. The reason FDA records is "Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered". 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-2231-2009
Status: Terminated
Initiated: 2009-07-17
Posted: 2009-09-22
Terminated: 2010-11-27
Recalling firm: Varian Medical Systems, Inc.
Product: Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.
Root cause tag: software
FDA root cause: Software design
Action: Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned.
Quantity in commerce: 1
Distribution: Product was distributed to one user in Texas
Product codes and lots: Model number H48, code number H484023.

Product code MUJ

K071873Class IIModification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. / cleared 2007-08-09

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)