Artis pheno with software VE20C- diagnostic imaging recall: Software Issue
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Why was Artis pheno with software VE20C- diagnostic imaging 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 164719 164712 164722 164723 164728 164711 164718 164703 164721 164726 164724 164725 UDI: 04056869046877
- Product
- Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 12 units
- Distribution
- US Nationwide distribution.
- Recall date
- February 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)