FDAClass IINovember 21, 2018

ARTIS zee biplane systems with Material 10094141- a recall

ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for…

Why was ARTIS zee biplane systems with Material 10094141- a recalled?

Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support

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: Serial 155122 155149 155151 155105 155148 154671 155126 155131 155132 155119 155121 155118 155147

Product
ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
14 units
Distribution
US Nationwide Distribution
Recall date
November 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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