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U.S. Department of Health and Human Services

Class 2 Device Recall LANTIS Commander, 10 Users, LANTIS 6.1 Commander and LANTIS 8.3 Commander

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  Class 2 Device Recall LANTIS Commander, 10 Users, LANTIS 6.1 Commander and LANTIS 8.3 Commander see related information
Date Initiated by Firm January 21, 2015
Date Posted March 16, 2015
Recall Status1 Terminated 3 on July 30, 2015
Recall Number Z-1282-2015
Recall Event ID 70384
510(K)Number K972275  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
Code Information Models: 04503178, 05493072, 08148178 with various serial numbers: 93-0938 93-1010 93-0730 93-0454 93-0759 93-0848 93-0884 93-1158 93-0037 93-1053 93-0726 93-0588 93-0693 93-0614 93-0566 93-0648 93-0803 93-0813 93-1387 93-0278 93-0856 93-0657 93-0222 93-1438 93-0662 93-0779 93-0732 93-0841 93-1045 93-0487 93-0564 93-0261 93-0096 93-0846 93-0574 93-0668 93-0887 93-1145 93-0102 93-0764 93-0501 93-0490 93-0739 93-1133 93-0159 93-0872 93-1531 93-0660 93-0798 93-0393 93-0738 93-1296 93-0623 93-0370 93-0951 93-0667 93-1135 93-0141 93-0786 93-0483 93-0385 93-1314 93-0799 93-0456 93-0416 93-0838 93-0639 93-0659 93-0760 93-0608 93-0766 93-0063 93-0878 93-0861 93-0452 93-0533 93-0272 93-0724 93-0596 93-0831 93-0398 93-0870 93-0874 93-0789 93-0686 93-0475 93-1185 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 There is a potential safety risk when using LANTIS server software with operating systems with which it has not been validated or released which can lead to an incorrect treatment to the patient.
FDA Determined
Cause 2		 Use error
Action Siemens sent an Customer Advisory Notice, dated January 21, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed the risk associated with use of more recent operating systems with LANTIS Server Software. Customers were warned against the use of more recent operating systems to ensure the LANTIS system remains in the validated configuration. In the interest of safety, we ask you to perform the above preventive measures and inform all affected personnel immediately. Please include this Field Safety Notice in your System Owner Manual chapter "Safety Advisory Letters" where it should remain. The relevant National Competent Authority will be informed of this Field Safety Notice. Please forward this safety information to other organizations that could be affected by this measure. If the device has been sold and therefore no longer in your possession, please forward this customer notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this notice until the update has been fully completed. We apologize for any inconvenience and thank you for your cooperation. For further questions please call (610) 219-6300.
Quantity in Commerce 87
Distribution Nationwide Distribution
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 = SIEMENS MEDICAL SOLUTIONS USA, INC.
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