FDAClass IIApril 27, 2022

Artis zee floor MN recall

Artis zee floor MN, Model Number 10094142

Why was Artis zee floor 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: 4056869010090; Serial Numbers: 140421 140115 140101 140205 140213 140204 140209 140219 140224 140218 140226 140221 140220 140206 140105 140423 140406 140422 140102 140214 140109 140202 140424 140114

Product
Artis zee floor MN, Model Number 10094142
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
24 systems
Distribution
US Nationwide.
Recall date
April 27, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls