Artis icono floor with software VE20C-diagnostic recall: Software Issue
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Why was Artis icono floor with software VE20C-diagnostic 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: 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
- Product
- Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 23 units
- Distribution
- US Nationwide distribution.
- Recall date
- February 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)