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U.S. Department of Health and Human Services

Class 2 Device Recall Millenium MLC Software Suite

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  Class 2 Device Recall Millenium MLC Software Suite see related information
Date Initiated by Firm May 27, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on December 20, 2004
Recall Number Z-1084-04
Recall Event ID 29338
510(K)Number K990085  
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product Linear accelerator workstation software suite
Code Information MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
3100 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Varian Oncology Helpdesk
888-827-4265
Manufacturer Reason
for Recall		 An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1
FDA Determined
Cause 2		 Software design
Action Varian will notify customers via phone beginning 5/27/2004 and distribute a product notification letters June 3, 2004, notifying them of the anomaly and corrective action, and finally, the anomaly will be corrected by a future release of software.
Quantity in Commerce 155 units
Distribution units were distributed throughout the US and Canada, as well as approximately 66 other foreign consignees, including
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VARIAN ASSOC., INC.
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