medical Class II Updated 2022-02-02

Siemens Medical Solutions USA, Inc recalls Artis icono floor with software VE20C-diagnostic imaging ang

Recalled Product

Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700

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

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 170319 170026 170343 170305 170307 170331 170309 170310 170023 170304 170328 170334 170336 170025 170346 170051 170333 170332 170312 170027 170303 170322 170053 UDI: 04056869149325
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