Philips Veradius Unity Foot Switch May Emit Unintended Radiation
Philips is recalling Veradius Unity radiological devices because the wireless foot switch may stick in the active position, causing unintended radiation emission during medical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall where a malfunction in a critical component (stuck wireless foot switch) creates the risk of unintended radiation exposure to patients and medical staff. The hazard involves ionizing radiation in a clinical setting; no illnesses have been reported, meeting the rubric criterion for high-risk harm products where injury has not yet been realized.
Plain-English summary
Philips North America LLC is recalling the Veradius Unity radiological guidance and visualization device (Product Code 718132) distributed in the United States. The device is used to provide radiological guidance during diagnostic, interventional, and surgical procedures on patients except newborns.
A wireless foot switch pedal used with the device may become stuck in the active position when the user releases it. When stuck, the switch remains activated and causes the device to emit radiation unintentionally. This malfunction can result in unexpected radiation exposure to patients and medical personnel during procedures.
The recall affects devices with multiple wireless foot switch model numbers and related components. Patients and healthcare providers using this equipment should contact Philips for instructions on remediation options.
No illnesses or injuries have been reported to date, but the potential for unintended radiation exposure represents a patient safety risk.
The recalled product
- 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.
- Manufacturer
- Philips North America Llc
- Hazard
- unintended-radiation
- stuck-switch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Product UDI: (01)00884838058194(21) 459801442981
- Wireless foot switch set 3P (WFSS 3P) 459801238231
- Wireless foot switch 3P
- 459801257861
- WFS Base Station 459800627394
- Wireless foot switch set 3P 459800415535
- 459800415542
- WFS Base Station
Distribution
Distribution scope not specified by the agency.
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