Device product

Azurion

Z-2403-2023

July 19, 2023

Class II

Product summary

Firm: Philips Medical Systems Nederland B.V.
Event: Event 92855
Status: Ongoing
Classification: Class II
Quantity: 5432 systems in total
Official record key: device-enforcement:Z-2403-2023

Official wording

Reason: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Code information: Azurion series

Distribution pattern: US Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation