| Date Initiated by Firm | May 06, 2014 |
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| Date Posted | June 20, 2014 |
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| Recall Status1 |
Terminated 3 on December 15, 2014 |
| Recall Number | Z-1840-2014 |
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| Recall Event ID |
68379 |
| 510(K)Number | K972275 |
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| Product Classification |
Accelerator, linear, medical - Product Code IYE
|
| Product | Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander
The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer. |
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| Code Information |
Material nos.: 4503178, 5493072, and 8148178 with serial nos.: 93-0695 93-0693 93-0938 93-1010 93-0730 93-0454 93-0759 93-0848 93-0884 93-1158 93-0584 93-0037 93-1053 93-0726 93-0588 93-0614 93-0566 93-1038 93-0648 93-0803 93-0813 93-1387 93-0278 93-0856 93-0314 93-0657 93-0222 93-1438 93-0662 93-0779 93-0732 93-0841 93-1045 93-0487 93-0564 93-0577 93-0792 93-0231 93-0096 93-0846 93-0574 93-0668 93-0634 93-0887 93-1145 93-0818 93-0102 93-0764 93-0501 93-0490 93-0261 93-0570 93-0739 93-1133 93-0159 93-0872 93-1531 93-0660 93-0798 93-0528 93-0326 93-0393 93-0738 93-0545 93-1296 93-0623 93-0370 93-1381 93-0951 93-0667 93-1135 93-0141 93-0786 93-0483 93-0385 93-0694 93-0883 93-1314 93-1320 93-0799 93-0456 93-0416 93-0838 93-0639 93-0659 93-0760 93-0608 93-0766 93-0912 93-0063 93-0262 93-0878 93-0861 93-0452 93-0533 93-0272 93-0724 93-0596 93-0831 93-0398 93-0805 93-0870 93-0874 93-0789 93-0686 93-0475 93-0748 93-1185 |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
|
| For Additional Information Contact | Customer Support
610-219-6300 |
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Manufacturer Reason
for Recall | There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data, such as treatment records, and LANTIS database corruption. |
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FDA Determined
Cause 2 | Use error |
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| Action | Siemens sent an Urgent Medical Device Correction Field Safety Notice dated was sent to end users on/about May 6, 2014, to notify them of the safety issue and provide instructions to avoid potential risks. Customers were instructed to make sure all computers with the LANTIS client software installed are running on an operating system that was validated by Siemens for opration with LANTIS, e.g. Microsoft Windows XP Service Pack 3 (SP3). Customers were asked to include the Field Safety Notice in their System Owner Manual chapter "Safety Advisory Letters" where it should remain and that all affected personnel affected be informed.
For questions regarding this recall call 1-610-219-6300. |
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| Quantity in Commerce | 108 |
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| Distribution | Nationwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = IYE
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