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.
This recall has been terminated (originally issued October 22, 2008).
- Recall Initiated
- June 2, 2008
- Posted
- October 22, 2008
- Terminated
- May 3, 2011
- Recall Number
- Z-0164-2009
- Quantity
- 18
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK.
Lot / Code Info
H462082, H463052, H462031, H463016, H462001, H462075, H462079, H462005, H462006, H462016, H462017, H462021, H462022, H462023, H462024, H463024, H463377, H463017.
Root Cause
Software design
Action Taken
Recall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees.
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