FDAClass IIMarch 31, 2021

Interventional Fluoroscopic X-Ray System - Product recall

Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including…

Why was Interventional Fluoroscopic X-Ray System - Product recalled?

Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.

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?

ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700

Product
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
29 systems
Distribution
US Nationwide distribution in the states of MI, KY, TX.
Recall date
March 31, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls