Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Reported: February 2, 2022 Initiated: October 12, 2021 #Z-0517-2022
Product Description
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 23 units
- Distribution
- US Nationwide distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 23 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 2, 2022. Severity: Moderate. Recall number: Z-0517-2022.
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