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U.S. Department of Health and Human Services

Class 2 Device Recall LANTIS Verify and Record software with XLINK option for Varian MLC

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 Class 2 Device Recall LANTIS Verify and Record software with XLINK option for Varian MLCsee related information
Date Initiated by FirmJuly 07, 2006
Date PostedAugust 11, 2006
Recall Status1 Terminated 3 on March 26, 2008
Recall NumberZ-1401-06
Recall Event ID 35982
510(K)NumberK981313 
Product Classification Impac MultiAccess Sequencer - Product Code IYE
ProductLANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface
Code Information Site Numbers: 93-0452, 93-0494, 93-0571, 93-0724, 93-0881, 93-0894, 93-0902, 93-0443, 93-0776, 93-0677, 93-1032, 93-0880, 93-0010, 93-0095, 93-0432, 93-0991, 93-0711, 93-0007, 93-0641, 93-0356, 93-0391, 93-0015, 93-0118
FEI Number 2937457
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
Manufacturer Reason
for Recall		Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.
FDA Determined
Cause 2		Software design
ActionThe firm has issued a safety advisory letter to all affected consignees, and will distribute an updated software version as soon as it is available.
Quantity in Commerce23 units
DistributionWorldwide Distribution --- USA and countries including Australia, China, Denmark, Germany, New Zealand, Portugal, Russia, Singapore, South Africa, Sweden and Switzerland
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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