FDAClass IIJune 15, 2022

Artis icono floor-angiography systems developed for recall

Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

Why was Artis icono floor-angiography systems developed for recalled?

if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053

Product
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
13 units
Distribution
US Nationwide distribution.
Recall date
June 15, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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