Recall Z-1282-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1282-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-21

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-01-21, terminated 2015-07-30. It names one FDA 510(k) clearance: K972275. Product: Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories. Reason: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-01-21
Terminated: 2015-07-30
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K972275 — LANTIS TREATSTATIONSiemens Medical Solutions USA, Inc.·cleared 1997-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.