FDA Enforcement
Class II
Ongoing
Azurion
Recall: Z-2403-2023
·
Reported September 13, 2023
Enforcement
- Recall Number
- Z-2403-2023
- Event ID
- 92855
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Medical Systems Nederland B.V.
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- September 13, 2023
- Initiation Date
- July 19, 2023
- Classification Date
- September 7, 2023
- Address
- High Tech Campus 36, N/A, Eindhoven, N/A, N/A, Netherlands
Description
Azurion
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 Info
Azurion series
Distribution
US Nationwide Distribution
Quantity
5432 systems in total