FDA-Device2022-02-02Class II
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Siemens Medical Solutions USA, Inc
Hazard
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
Sold states
US Nationwide distribution.
Affected count
12 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0515-2022Don't want to check this manually?
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