Recall Z-0515-2022— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0515-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-12

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2021-10-12, terminated 2024-04-11. It names one FDA 510(k) clearance: K201156. Product: Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000. 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: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2021-10-12
Terminated: 2024-04-11
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K201156 — ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.·cleared 2020-06-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.