PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 2, 2014 Initiated: May 6, 2014 #Z-1840-2014

Product Description

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.

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.

Details

Units Affected
108
Distribution
Nationwide Distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 108.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on July 2, 2014. Severity: Moderate. Recall number: Z-1840-2014.