Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the

FDA device recall Z-1840-2014 · posted 2014-06-20 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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.

Action taken

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.

Root cause

Use error

Status

Terminated

Product code

IYE

Quantity affected

108

Distribution

Nationwide Distribution

Date initiated

2014-05-06

Date posted

2014-06-20

Date terminated

2014-12-15

Location

Malvern, PA

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