Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling 12 Artis pheno diagnostic imaging angiography systems with software VE20C due to four potential software issues. These issues include: updated calibration data not being saved after certain measurements, the system becoming unable to produce x-rays and potentially requiring shutdown and restart during medical procedures, corrupted images appearing during roadmap functions, and unintended system shutdowns in units equipped with uninterruptible power supply options. The affected systems were distributed nationwide and can be identified by their specific serial numbers ranging from 164703 to 164728.
The recall affects a limited number of units that were distributed across the United States. The source document does not specify a remedy or recommended 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: 12 units Lot/code info: Serial Numbers: 164719 164712 164722 164723 164728 164711 164718 164703 164721 164726 164724 164725 UDI: 04056869046877
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.