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U.S. Department of Health and Human Services

Class 2 Device Recall HighDefinition 120 MultiLeaf Collimator

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  Class 2 Device Recall HighDefinition 120 MultiLeaf Collimator see related information
Date Initiated by Firm January 30, 2008
Date Posted August 02, 2008
Recall Status1 Terminated 3 on August 18, 2010
Recall Number Z-1459-2008
Recall Event ID 46852
510(K)Number K071992  
Product Classification Medical charged-particle radiation therapy system - Product Code IYE
Product High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator.
Code Information Serial Number 1009.
Recalling Firm/
Manufacturer		 Varian Medical Systems Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact
650-424-5731
Manufacturer Reason
for Recall		 Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient.
FDA Determined
Cause 2		 Software design
Action Consignees were notified by a Medical Device Notification letter sent on 01/29/2008. The letter advised users to cease use of the device until a corrected version of the software is available. A representative will contact users to upgrade the application once the revised software has been validated and released for distribution.
Quantity in Commerce 3 units subject to correction
Distribution Nationwide Distribution including states of NC, FL and CA.
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 MEDICAL SYSTEMS
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