AXIOM Artis or Artis zee system Product Usage: Axiom recall
AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane…
Why was AXIOM Artis or Artis zee system Product Usage: Axiom recalled?
There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.
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?
material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959
- Product
- AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 1067
- Distribution
- US Nationwide Distribution.
- Recall date
- October 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)