ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
FDA Recall #Z-0956-2023 — Class II — December 16, 2022
Product Description
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Reason for Recall
Mechanical connection between the tabletop and table base may be lost.
Recalling Firm
Siemens Medical Solutions USA, Inc — Malvern, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated