AXIOM Artis FA recall
AXIOM Artis FA, Model Number 5904441
Why was AXIOM Artis FA 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: 25328 25349 25382 25403
- Product
- AXIOM Artis FA, Model Number 5904441
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 4
- Distribution
- US Nationwide Distribution
- Recall date
- July 31, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)