FDA Enforcement
Class II
Terminated
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Recall: Z-0515-2022
·
Reported February 2, 2022
Enforcement
- Recall Number
- Z-0515-2022
- Event ID
- 89260
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 2, 2022
- Initiation Date
- October 12, 2021
- Classification Date
- January 21, 2022
- Termination Date
- April 11, 2024
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418, United States
Description
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Reason
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
Code Info
Serial Numbers: 164719 164712 164722 164723 164728 164711 164718 164703 164721 164726 164724 164725 UDI: 04056869046877
Distribution
US Nationwide distribution.
Quantity
12 units