Siemens Medical Solutions USA, Inc recalls Artis pheno with software VE20C- diagnostic imaging angiogr
Recalled Product
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Hazard / Issue
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
Issued by
FDA
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