Z-0164-2009

Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46...

Name: Z-0164-2009 Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46...
Creator: Varian Medical Systems Oncology Systems
Published: 2008-06-02
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2008-06-02 / Terminated / root cause: software

FDA source

Varian Medical Systems Oncology Systems began a recall of Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian... on 2008-06-02. The reason FDA records is "A malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect". 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-0164-2009
Status: Terminated
Initiated: 2008-06-02
Posted: 2008-10-22
Terminated: 2011-05-03
Recalling firm: Varian Medical Systems, Inc.
Product: Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing irradiation while any parameter is out of conformance with the treatment plan.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect.
Root cause tag: software
FDA root cause: Software design
Action: Recall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees.
Quantity in commerce: 18
Distribution: Worldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK.
Product codes and lots: H462082, H463052, H462031, H463016, H462001, H462075, H462079, H462005, H462006, H462016, H462017, H462021, H462022, H462023, H462024, H463024, H463377, H463017.

Product code IYE

K001643Class IIVaris 1.4GVarian Medical Systems, Inc. / cleared 2000-06-23

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)