Tomtec recalls ARENA TTA2 software versions 2.20 and lower due to potential mixing of study data between 3D applications. Affected units may store measurements from one study to another, risking incorrect medical results.
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.
Tomtec is recalling its ARENA TTA2 software versions 2.20 and lower because a software issue could cause measurements from one medical study to be stored incorrectly in another study. This might lead to inaccurate medical results if the software is used for clinical imaging.
The software issue affects how the Image-Com module stores measurements for 3D applications. If the system is used for clinical imaging, it could accidentally store data from one study into another study, potentially causing incorrect medical results.
Healthcare providers using the TOMTEC-ARENA TTA2 system with software versions 2.20 and lower are most at risk, particularly those handling medical imaging studies where data accuracy is critical.
Check if your TOMTEC-ARENA TTA2 system has software version 2.20 or lower. Affected versions include TTA 1.2, TTA2.00.01 through TTA2.20.18 with specific UDI codes listed in the recall notice.
Review your TOMTEC-ARENA TTA2 software version to confirm if it is 2.20 or lower.
Software versions 2.20 and lower, including TTA 1.2 through TTA2.20.18 with specific UDI codes.
The issue could cause measurements from one medical study to be stored incorrectly in another study, potentially leading to inaccurate medical results.
No action is needed if your software version is newer than 2.20.
We’ve drafted a message you can send Tomtec to request your refund or repair — edit it as you like.
Subject: Recall Z-2496-2020 — Tomtec Tomtec Hello, I own a Tomtec that is covered by recall Z-2496-2020 from Tomtec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
