Recall Z-1840-2014 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
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.
| Date | Jun 20, 2014 (initiated May 6, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Use error |
| 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 affe |
| Quantity | 108 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972275 | LANTIS TREATSTATION Siemens Medical Solutions USA, Inc., Sep 8, 1997 |