The Recall Desk

FDA (Devices) recall action 96593

Philips North America Llc recalled 3 products on 2025-04-30

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2025-04-30
Critical
0
Units
—

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • HighFDA (Devices)··2025-04-30

    Zenition 50 Medical Imaging Devices Wireless Foot Switch Recall

    Philips is recalling Zenition 50 medical imaging devices because the wireless foot switch pedal may get stuck in the active position, causing unintended radiation emission.

    Product
    Zenition 50. Product Code 718096. 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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-30

    Veradius Unity wireless foot switch pedal may emit unintended radiation

    Philips North America is recalling Veradius Unity foot switch pedals that may become stuck in the active position, causing unintended radiation emission during medical procedures.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-30

    Zenition 70 Radiological System Wireless Foot Switch Recall

    Philips is recalling Zenition 70 radiological systems with wireless foot switches that may stick in the active position when released, potentially causing unintended radiation emission during medical procedures.

    Product
    Zenition 70. Product Code 718133. 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.
    Category
    Distribution
    0 states