AXIOM Artis BA recall
AXIOM Artis BA, Model Number 5904656
Why was AXIOM Artis BA recalled?
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
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: 28159 28144 28154 28139 28155 28160 28156
- Product
- AXIOM Artis BA, Model Number 5904656
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 7
- Distribution
- US Nationwide Distribution
- Recall date
- July 31, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)