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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 Collimatorsee related information
Date Initiated by FirmJanuary 30, 2008
Date PostedAugust 02, 2008
Recall Status1 Terminated 3 on August 18, 2010
Recall NumberZ-1459-2008
Recall Event ID 46852
510(K)NumberK071992 
Product Classification Medical charged-particle radiation therapy system - Product Code IYE
ProductHigh-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
ActionConsignees 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 Commerce3 units subject to correction
DistributionNationwide Distribution including states of NC, FL and CA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYE
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