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Recall Observatory FDA recall evidence

Device product

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Z-0956-2023

December 16, 2022

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 91361
Status
Ongoing
Classification
Class II
Quantity
550 units
Official record key
device-enforcement:Z-0956-2023

Official wording

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

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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