FDA-Device2023-01-25Class II

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Siemens Medical Solutions USA, Inc
Hazard

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

Sold states
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.
Affected count
550 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0956-2023

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