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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM.GO TOP; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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SIEMENS HEALTHCARE GMBH SOMATOM.GO TOP; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number 11061640
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2019
Event Type  malfunction  
Manufacturer Narrative
Siemens has initiated a technical investigation of the reported event.A root-cause is not yet available.The system swivel arm was re-attached.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported to siemens that the somatomgo.Top injector arm swivel came apart.The injector arm swivel came apart above the "t" where the injector and storage box are located.The event did not occur during patient treatment and there were no reported injuries.
 
Manufacturer Narrative
The siemens evaluation identified a design issue as the root cause of the reported event.Every affected customer will be informed with a csan (ct043/19/s).An onsite check will be performed and if applicable an interim solution will be implemented at the site.A final solution (redesign) has to be developed and will be rolled out with ct048/19/s.The corrective action will be reported separately to the fda as a voluntary corrections and removal action.
 
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Brand Name
SOMATOM.GO TOP
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forchheim, 91301
GM  91301
MDR Report Key8758139
MDR Text Key190827559
Report Number3004977335-2019-85319
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K173632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11061640
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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