FDA-Device2023-09-13Class II
Azurion
Philips Medical Systems Nederland B.V.
Hazard
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Sold states
US Nationwide Distribution
Affected count
5432 systems in total
Manufactured in
High Tech Campus 36, N/A, Eindhoven, N/A, Netherlands
Products
Azurion
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2403-2023Don't want to check this manually?
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