AXIOM Artis BC recall
AXIOM Artis BC, Model Number 5904649
Why was AXIOM Artis BC 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: 14101 14111 14108 14099 14094 14112
- Product
- AXIOM Artis BC, Model Number 5904649
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 6
- Distribution
- US Nationwide Distribution
- Recall date
- July 31, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)