FDA-Device2019-07-31Class II
AXIOM Artis dFC, Model Number 7412807
Siemens Medical Solutions USA, Inc
Hazard
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Sold states
US Nationwide Distribution
Affected count
148
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
AXIOM Artis dFC, Model Number 7412807
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2020-2019Don't want to check this manually?
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