Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA is recalling 23 Artis icono floor diagnostic imaging angiography systems with software VE20C due to four potential software issues. These issues include updated calibration data not being saved after measurement adjustments, the system becoming unable to produce x-rays and potentially requiring shutdown and restart during medical interventions, corrupted images appearing during Roadmap functions, and unintended shutdowns of the imaging system when equipped with an Uninterruptible Power Supply (UPS) option. The affected systems were distributed nationwide across the United States.
The recall involves 23 specific units identified by their serial numbers. The source document does not specify any remedy, replacement, repair, or other corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: US Nationwide distribution. Quantity: 23 units 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.