FDAClass IISeptember 4, 2019

Artis zee and Artis Q/ Q.zen Interventional recall

Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane…

Why was Artis zee and Artis Q/ Q.zen Interventional recalled?

Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts

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: 123245 103302 121501 148401 109589 148393 111129 148400 103310 148397 155235 121505 109563 121506 131235 121502 105125

Product
Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
US 17
Distribution
US Nationwide Distribution - AL, AR, KS, MI, MN, NC, ND, NY, OH, SC, TX, WI
Recall date
September 4, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls