• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TOMTEC IMAGING SYSTEMS GMBH TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUATIFICATION 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 06/14/2016
Event Type  malfunction  
Manufacturer Narrative
A thorough evaluation of this event will be included in a follow-up report upon investigation completion.
 
Event Description
Customer reported that switching studies causes the measurement list to keep measurements from the previous study, and mixes them with those from the new one. Measurement list contains measurements from another study.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTOMTEC-ARENA TTA2
Type of DeviceIMAGE REVIEW AND QUATIFICATION SOFTWARE
Manufacturer (Section D)
TOMTEC IMAGING SYSTEMS GMBH
edisonstrasse 6
unterschleissheim, 85716
GM 85716
MDR Report Key9087767
MDR Text Key195108329
Report Number8043836-2019-00002
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
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 Number11.01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
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

-
-