FDA Medical Device Recalls (openFDA)
Varian Medical Systems Oncology Systems: 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.
- Recall number
- Z-0164-2009
- Recalling firm
- Varian Medical Systems Oncology Systems
- 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.
- Status
- Terminated
- Initiated
- 2008-06-02
- Posted
- 2008-10-22
- Terminated
- 2011-05-03
- Reason
- 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
- Software design
- Action
- Recall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees.
- Quantity
- 18
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK.
- Lot, serial or model codes
- H462082, H463052, H462031, H463016, H462001, H462075, H462079, H462005, H462006, H462016, H462017, H462021, H462022, H462023, H462024, H463024, H463377, H463017.
- 510(k) numbers
- ["K001643"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2916710
- Firm city
- Palo Alto
- Firm state
- CA
- 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