Artis One recall
Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional…
Why was Artis One recalled?
After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.
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 # 82010, material # 10848600
- Product
- Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 1 angiography system
- Distribution
- Nationwide Distribution to Michigan only
- Recall date
- April 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)