FDA-Device2023-01-25Class II
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
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-0956-2023More Siemens Medical Solutions USA, Inc recalls
- FDA-Device2026-07-08ARTIS icono ceiling. Model Number: 11328100.
- FDA-Device2026-07-08ARTIS icono floor. Model Number: 11327700.
- FDA-Device2026-07-08ARTIS icono biplane. Model Number: 11327600.
- FDA-Device2026-07-08ARTIS icono ceiling. Model Number: 11328100.
- FDA-Device2026-04-22Siemens ARTIS Pheno VE30A and VE40A imaging system recalled for potential unintended radiation exposure
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