FDAClass IIDecember 1, 2021

Artis Q.zen ceiling with software VD12-angiography recall

Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model…

Why was Artis Q.zen ceiling with software VD12-angiography recalled?

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

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 111502 111503 111510 111507 111512 111508 111133 111504 111506 111513 111500 111501 111505 111514

Product
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
15 units
Distribution
US Nationwide Distribution
Recall date
December 1, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls