Z-2402-2023 Class II Ongoing
FDA device recall Z-2402-2023 was initiated by Philips Medical Systems Nederland B.V. on July 19, 2023 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 5432 systems in total.
Recall Details
- Product Type
- Devices
- Report Date
- September 13, 2023
- Initiation Date
- July 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 5432 systems in total
Product Description
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 Pattern
US Nationwide Distribution
Code Information
Allura Xper series