Company: Tomtec Imaging Systems Gmbh
Date of Enforcement Report: 7/15/2020
Class II
PRODUCT
TOMTEC-ARENA TTA2 (sw version no. 2.20 and lower) Picture archiving and communications system.
Recall Number: Z-2496-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
Tomtec Imaging Systems Gmbh on 9/23/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
U.S. Nationwide and International