FDAClass IIDecember 1, 2021

Artis zee multi-purpose with software VD12-angiography recall

Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model…

Why was Artis zee multi-purpose 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: 159030 159034 159038 159032 159046 159054 159015 159058 159028 159037 159026 159042 159047 159025 159024 159021 159041 159049 159010 Expanded Recall 11/15/21: 159065

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