Z-0515-2022 Class II Terminated
FDA device recall Z-0515-2022 was initiated by Siemens Medical Solutions USA, Inc on October 12, 2021 and is designated Class II. 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 shutdow… The recall status is terminated (terminated April 11, 2024). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 2, 2022
- Initiation Date
- October 12, 2021
- Termination Date
- April 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
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 Pattern
US Nationwide distribution.
Code Information
Serial Numbers: 164719 164712 164722 164723 164728 164711 164718 164703 164721 164726 164724 164725 UDI: 04056869046877