FDAClass IINovember 10, 2021

Artis zeego recall: Software Issue

Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software…

Why was Artis zeego recalled?

Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient

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?

Artis zeego systems with Artis patient table and AppSW VD20C/VD20N

Product
Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
43 US
Distribution
US Nationwide distribution.
Recall date
November 10, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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