FDA-Device2022-02-02Class II
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
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
72 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief