Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25638 |
| Brand Name: | TomTec_41670_IIa_TomTec-Arena and Image-Arena |
| Model: | TOMTEC-ARENA TTA2 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Clinical & Regulatory Services Limited 30 Fulford Road Havelock North Hastings 4130 |
| Contact Information: | (06) 844 4490 |
| Manufacturer: | TomTec Imaging Systems GmbH |
| Issue: | The manufacturer has identified a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the TOMTEC-ARENA software. Measurements from one study might be stored to another study. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/2/2020 |
