Tomtec ARENA TTA2 Software Recalled for Potential Data Storage Error
Tomtec Imaging Systems is recalling ARENA TTA2 software versions 2.20 and lower because measurements from one study might be stored to another.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving a software defect without reported harm.
Plain-English summary
Tomtec Imaging Systems Gmbh is recalling the TOMTEC-ARENA TTA2 picture archiving and communications system, specifically software version 2.20 and lower. The recall involves 62 units distributed across 15 U.S. states and 10 international countries. The affected software includes specific modules such as 4D LV-Analysis, 4D RV-Function, and 3D Cardio-View.
The firm discovered a software issue associated with the Image-Com module interface for 3D applications. This defect may cause measurements from one study to be stored to another study. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users of the affected software should contact Tomtec Imaging Systems for instructions on how to resolve the issue. The recall is classified as Class II by the FDA.
The recalled product
- 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…
- Manufacturer
- Tomtec Imaging Systems Gmbh
- Category
- Medical Device — Software
- Hazard
- Affected units
- 62
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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.
Distribution
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