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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHINEERS GMBH LANTIS SYSTEM; ACCELERATOR, LINEAR, MEDICAL
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SIEMENS HEALTHINEERS GMBH LANTIS SYSTEM; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Device Problem Computer System Security Problem (2899)
Patient Problem No Patient Involvement (2645)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Siemens has released a customer communication ((b)(4)) informing customers of potential (b)(6) vulnerability to the "wannacry" malware that could potentially affect a lantis server system.Siemens has also released (b)(6) for syngo workplaces ((b)(4)) that fixes a security vulnerability exploited by the "wannacry" virus.
 
Event Description
Siemens has become aware of lantis systems that have been identified as being vulnerable to the malware "wannacry", which encrypts data files with the intention of exploiting this vulnerability that would allow remote code execution to infect the systems with this malware.Files on the computer may become encrypted and the information in these files may not be accessible for patient treatments.If a system were to become infected, patient data would be encrypted and depending on the date and time of the last available data backup, there is the possibility of a previously treated fraction being treated again.This could lead to an overdose to a patient.However, to date siemens has not received any reports of malware infection of siemens radiation oncology devices.
 
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Brand Name
LANTIS SYSTEM
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
SIEMENS HEALTHINEERS GMBH
roentgen strasse 19-21
kemnath, 95478
GM  95478
Manufacturer (Section G)
SIEMENS HEALTHINEERS GMBH
roentgen strasse 19-21
kemnath, 95478
GM   95478
Manufacturer Contact
marlynne galloway
40 liberty boulevard
mc: 65-1a
malvern, PA 19355-9998
6104486471
MDR Report Key6673272
MDR Text Key78590792
Report Number3002466018-2017-82774
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K972275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/26/2017,05/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/26/2017
Distributor Facility Aware Date05/30/2017
Event Location Other
Date Report to Manufacturer06/26/2017
Date Manufacturer Received05/30/2017
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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