Reported Jul 15, 2020 · Ongoing
TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions…
Tomtec Imaging Systems GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tomtec Imaging Systems Gmbh · Edisonstr. 6 · Unterschleisheim · N/A
Is this the product you have?
TOMTEC-ARENA TTA2software version no. 2.20 and lowerPicture archiving and communications system
- Software Versions and applicable UDITTA 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
- Lot codes and dates
- 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.
- Amount recalled
- 62 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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