Retiro De Equipo (Recall) de Device Recall Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander

Recall

68379

Class 2

Z-1840-2014

2014-05-06

2014-06-20

Terminated

United States

2014-12-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127491

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.

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.