FDA recall Z-0516-2022

Siemens Medical Solutions USA, Inc · Class II · device

Product

Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

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.

Key facts

Status: Terminated
Initiation date: 2021-10-12
Report date: 2022-02-02
Termination date: 2024-04-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2022