Artis One recall
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese…
Why was Artis One recalled?
The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.
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?
Model Number 10848600, serial number 82010
- Product
- Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 1
- Distribution
- Nationwide Distribution to MI only
- Recall date
- February 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)