Recall of Device Recall LANTIS Commander, 10 Users, LANTIS 6.1 Commander and LANTIS 8.3 Commander

Recall

70384

Class 2

Z-1282-2015

2015-01-21

2015-03-16

Terminated

United States

2015-07-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133396

There is a potential safety risk when using lantis server software with operating systems with which it has not been validated or released which can lead to an incorrect treatment to the patient.

Siemens sent an Customer Advisory Notice, dated January 21, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed the risk associated with use of more recent operating systems with LANTIS Server Software. Customers were warned against the use of more recent operating systems to ensure the LANTIS system remains in the validated configuration. In the interest of safety, we ask you to perform the above preventive measures and inform all affected personnel immediately. Please include this Field Safety Notice in your System Owner Manual chapter "Safety Advisory Letters" where it should remain. The relevant National Competent Authority will be informed of this Field Safety Notice. Please forward this safety information to other organizations that could be affected by this measure. If the device has been sold and therefore no longer in your possession, please forward this customer notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this notice until the update has been fully completed. We apologize for any inconvenience and thank you for your cooperation. For further questions please call (610) 219-6300.