FDA Enforcement
Class II
Terminated
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Recall: Z-0517-2022
·
Reported February 2, 2022
Enforcement
- Recall Number
- Z-0517-2022
- 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 icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
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: 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
Distribution
US Nationwide distribution.
Quantity
23 units