FDA recall Z-0956-2023

Siemens Medical Solutions USA, Inc · Class II · device

Product

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Reason for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2022-12-16
Report date
2023-01-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

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