TOMTEC-ARENA TTA2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04260361440143), received between Aug 16, 2018 and Apr 1, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Patient Data Problem” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2020Patient Data Problem

  THE WORKFLOW TRIGGERING THE EVENT INVOLVES MULTIPLE SYSTEMS: MEASUREMENTS ARE DONE ON THE ULTRASOUND MODALITY AND THEN STUDIES ARE SENT IN TO ENTERPRISE IMAGING (EI) FROM AGFA. FROM EI CLIENT THE STUDIES ARE OPENED IN TOMTEC-ARENA FROM TOMTEC AND THE MEASUREMENTS ARE THEN EXPORTED VIA XML FILE TO THE CUPID SYSTEM FROM EPIC FOR REPORTING PURPOSE. IN SOME CIRCUMSTANCES IT HAPPENS THAT THE MEASUREMENTS FROM THE PREVIOUS PATIENT\STUDY IS SENT ADDITIONALLY TO EPIC CUPID FOR THE CURRENT ONE HOWEVER WITH THE CURRENT PATIENTS\STUDY DETAILS. THE SOFTWARE IS USED IN CLINICAL ROUTINE, THERE WAS NO INJURY OR SERIOUS DETERIORATION OF HEALTH STATE REPORTED WITH THIS EVENT. FIRST INVESTIGATIONS SHOW THAT THE ADDITION OF PREVIOUS MEASUREMENT DATA TO THE CURRENT EXPORT IS RELATED TO NONIMAGECOMFINDINGS (=IMPORTED MEASUREMENTS THAT ARE NOT MAPPED AND DISPLAYED IN THE EI/TOMTEC-ARENA SYSTEM BUT PASSED TO THE CUPID SYSTEM). IT ONLY HAPPENS IN CASE OF STUDIES ARE LAUNCHED WITHOUT NONIMAGECOMFINDINGS AND THE PREVIOUS LAUNCHED STUDY CONTAINED NONIMAGECOMFINDINGS. ALSO THE CONFIGURATION FLAG PASS THROUGH MEASUREMENTS FOR TOMTEC-ARENA NEEDS TO BE SET TO TRUE AND THE INTEGRATION SCENARIO OF TOMTEC-ARENA INT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9911027 ↗
• MalfunctionNov 15, 2019Patient Data Problem; Patient Data Problem

  IT WAS REPORTED THAT WHILE USING TOMTEC-ARENA ZERO IF TWO TABS ARE OPEN ON THE BROWSER AT THE SAME TIME, IF THE USER SWITCHES FROM ONE TAB TO THE OTHER, THEN THE PATIENT INFORMATION FROM THE FIRST TAB IS COPIED TO THE PATIENT STUDY ON THE SECOND TAB.TO DATE NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9328104 ↗
• MalfunctionSep 19, 2019Patient Data Problem; Patient Data Problem

  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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086360 ↗
• MalfunctionAug 24, 2018Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED A PATIENT DATA ERROR WHILE USING THE TOMTEC-ARENA. THE SOFTWARE ALLOWED PATIENT DATA ACQUIRED FROM ONE DATA SET TO BE INCLUDED IN THE NEXT PATIENT STUDY. THERE WAS NO MISDIAGNOSIS OR INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812174 ↗
• MalfunctionAug 16, 2018Patient Data Problem; Patient Data Problem

  A CUSTOMER REPORTED A PATIENT DATA ERROR WHILE USING THE TOMTEC-ARENA. THE SOFTWARE ALLOWED PATIENT DATA ACQUIRED FROM ONE DATA SET TO BE INCLUDED IN THE NEXT PATIENT STUDY. THERE WAS NO MISDIAGNOSIS OR INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788665 ↗