FDASeptember 23, 2019device
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 UD...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
tomtec imaging systemstomtectomtec imaging
UPCs
04260361440143
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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