FDA-Device2023-05-03Class II
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Siemens Medical Solutions USA, Inc
Hazard
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
Sold states
Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia, Iraq, Japan, Malaysia, Morocco, Nepal, Nigeria, Poland, Russia, Rwanda, Serbia, Slovenia, South Africa, Spain, Sudan, Syria, Taiwan, Thailand, Uganda, Ukraine, United Kingdom, Uzbekistan, Vietnam.
Affected count
4 units US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1469-2023Don't want to check this manually?
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