FDA recall Z-2402-2023
Philips Medical Systems Nederland B.V. · Class II · device
Product
Allura Xper series
Reason for recall
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Distribution
US Nationwide Distribution
Key facts
- Status
- Ongoing
- Initiation date
- 2023-07-19
- Report date
- 2023-09-13
- Voluntary/Mandated
- FDA Mandated
- Location
- Eindhoven, N/A, Netherlands
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2402-2023