FDAClass IISeptember 4, 2013

Axiom Artis systems. C-arm angiographic x-ray system recall

Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

Why was Axiom Artis systems. C-arm angiographic x-ray system recalled?

The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.

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?

Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509.

Product
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
178
Distribution
US Distribution including the states of PA, NJ, DC, VA, MD and DE.
Recall date
September 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls