MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH LANTIS ONCOLOGY INFORMATION SYSTEM; ACCELERATOR, LINEAR, MEDICAL

Model Number 5835991

Device Problem Application Security Problem (2882)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens will prepare a field safety notification to inform customers about the potential vulnerability.

Event Description

Siemens became aware of a microsoft service 2003 ((b)(4)) vulnerability affecting remote desktop services on which the lantis oncology information system runs.This issue was reported internally at siemens.The precondition for this vulnerability to be misused is activated remote desktops services with open port 3389.Even though remote desktop services including the required port were not reported to be activated in the associated service instructions, siemens cannot exclude that systems in the field may be vulnerable.To present, no exploits have been reported from the field and siemens is not aware of any lantis security incidents due to this vulnerability.The described vulnerability is related to the operating system microsoft server 2003 and not to the lantis application.In a worst case scenario, this vulnerability could be exploited to infect the lantis system which could result to patient mistreatment (dose to wrong location).A partial loss of patient data could also occur (i.E.An offset [position correction] is lost).If this issue is not discovered it may result in an incorrect patient position for the following fractions, leading to a larger dose to a critical organ than expected and severe bodily injury.The reported event occurred in (b)(6).

• Brand Name: LANTIS ONCOLOGY INFORMATION SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 8664546
• MDR Text Key: 210469030
• Report Number: 3002466018-2019-82826
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5835991
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1