Recall – PACS software issue may lead to study results mismatch

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

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