FDAClass IIJanuary 25, 2023

ARTIS pheno recall

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Why was ARTIS pheno recalled?

Mechanical connection between the tabletop and table base may be lost.

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?

1) ARTIS pheno; Material #10849000; UDI/DI: 4056869046877 2) ARTIS icono biplane; Material #11327600; UDI/DI: 4056869063317 3) ARTIS icono floor; Material #11327700; UDI/DI: 4056869149325

Product
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
550 units
Distribution
Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kuwait, Lebanon, Monaco, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.
Recall date
January 25, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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