Recall – Multiple software issues with angiography system

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 2/2/2022
Class II

PRODUCT

Artis pheno with software VE20C- diagnostic imaging angiography system

Model: 10849000

Recall Number: Z-0515-2022

REASON

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 10/12/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

12 units

DISTRIBUTION

U.S. Nationwide

Corporate Office

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