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Class 2 Device Recall Varian RV Software |
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Date Initiated by Firm |
June 02, 2008 |
Date Posted |
October 22, 2008 |
Recall Status1 |
Terminated 3 on May 03, 2011 |
Recall Number |
Z-0164-2009 |
Recall Event ID |
48661 |
510(K)Number |
K001643
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Product Classification |
Medical Linear Accelerator - Product Code IYE
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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.
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Code Information |
H462082, H463052, H462031, H463016, H462001, H462075, H462079, H462005, H462006, H462016, H462017, H462021, H462022, H462023, H462024, H463024, H463377, H463017. |
Recalling Firm/ Manufacturer |
Varian Medical Systems Oncology Systems 911 Hansen Way Palo Alto CA 94304-1028
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For Additional Information Contact |
650-424-5731
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Manufacturer 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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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