Philips North America Llc: Device Recall
Recall #Z-1582-2025 · 02/25/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1582-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Philips North America Llc
- Status
- Ongoing
- Date Initiated
- 02/25/2025
- Location
- Cambridge, MA, United States
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- N/A
Reason for Recall
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Product Description
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Distribution Pattern
US
Other Recalls by Philips North America Llc
- Class II: Risk 12/12/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.