FDAClass IIJanuary 22, 2020

Siemens ARTIS pheno recall

Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic…

Why was Siemens ARTIS pheno recalled?

The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.

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 164231, 164234, 164240, 164241, 164242, 164244

Product
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
6
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
Recall date
January 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls