CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report
Siemens Lantis System ; Lantis Commander, 10 Users recalled
Siemens Medical Solutions USA is recalling Siemens Lantis System ; Lantis Commander, 10 Users ; Lantis 1 Commander ; Lantis 3, distributed nationwide in the US. The recall was initiated on 6 May 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1840-2014
- FDA event ID
- 68379
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 May 2014
- FDA classified
- 20 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 6 May 2014 | Recall initiated by company | |
| 20 Jun 2014 | Classified by FDA | +45 days |
| 2 Jul 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Siemens Lantis System ; Lantis Commander, 10 Users ; Lantis 1 Commander ; Lantis 3 recalled?
Yes. Siemens Medical Solutions USA recalled Siemens Lantis System ; Lantis Commander, 10 Users ; Lantis 1 Commander ; Lantis 3 on 6 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1840-2014.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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