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