FDAClass IIJuly 31, 2019

AXIOM Artis TA recall

AXIOM Artis TA, Model Number 7007755

Why was AXIOM Artis TA 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: 32090 32085 32091 32094 32095

Product
AXIOM Artis TA, Model Number 7007755
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
5
Distribution
US Nationwide Distribution
Recall date
July 31, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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