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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOMTEC IMAGING SYSTEMS GMBH TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUANTIFICATION SOFTWARE

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TOMTEC IMAGING SYSTEMS GMBH TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUANTIFICATION SOFTWARE Back to Search Results
Model Number TTA2
Device Problem Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2019
Event Type  malfunction  
Manufacturer Narrative
A thorough evaluation of this event will be included in a follow-up report upon investigation completion.
 
Event Description
A customer reported measurement data can appear from a previous study onto a new study if an error message appears during launch while using the tomtec-arena tta 2. This event occurred during a research study. There was no injury or clinical use associated with this event.
 
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Brand NameTOMTEC-ARENA TTA2
Type of DeviceIMAGE REVIEW AND QUANTIFICATION SOFTWARE
Manufacturer (Section D)
TOMTEC IMAGING SYSTEMS GMBH
edisonstrasse 6
unterschleissheim, 85716
GM 85716
Manufacturer (Section G)
TOMTEC IMAGING SYSTEMS GMBH
edisonstrasse 6
unterschleissheim, 85716
GM 85716
Manufacturer Contact
gerald paul
edisonstrasse 6
unterschleissheim, 85716
GM   85716
MDR Report Key9086360
MDR Text Key203498196
Report Number8043836-2019-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150122
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTTA2
Device Lot Number20.14
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2019
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
Removal/Correction Number8043836-10/02/19-001-C

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