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Siemens Medical Solutions USA, Inc recalls Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Recalled February 2, 2022 · FDA recall Z-0517-2022 · Siemens Medical Solutions USA
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 · FDA Class II
Units
23 units
Sold at
US Nationwide distribution.
Description
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
Product
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →