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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.