FDA Device recall Z-2496-2020
TOMTEC-ARENA TTA2;software version no. 2.20 and lower
- FDA Device
- Class II
- ongoing
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of TOMTEC-ARENA TTA2;software version no. 2.20 and lower by Tomtec Imaging Systems, citing the firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2496-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-09-23 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Tomtec Imaging Systems |
| Distribution | AL, AZ, CA, CT, IL, MA, MI, NC, NJ, NY, OH, PA, RI, TX, VA |
Product
TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18
Reason
The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study.
Identifiers
| code_info | The affected product versions are TOMTEC-ARENA, TTA 2.20 and lower, with modules 4D LV-Analysis, 4D RV-Function, 4D MV-…The affected product versions are TOMTEC-ARENA, TTA 2.20 and lower, with modules 4D LV-Analysis, 4D RV-Function, 4D MV-Assessment, 3D Cardio-View, 4D Sono-Scan, Echo-Com, 2D Cardiac Performance Analysis, and QAngio. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2496-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.