FDAClass IINovember 23, 2016

AXIOM Artis recall

AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane…

Why was AXIOM Artis recalled?

The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.

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 Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392

Product
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
4,657 systems Worldwide
Distribution
US Nationwide Distribution.
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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