FDAClass IIApril 27, 2022

Artis zee biplane MN recall

Artis zee biplane MN, Model Number 10094143

Why was Artis zee biplane MN recalled?

If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI: 4056869010106; Serial Numbers: 149100 149401 149421 149106 149202 149420 149402

Product
Artis zee biplane MN, Model Number 10094143
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
7 systems
Distribution
US Nationwide.
Recall date
April 27, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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