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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II recall from the FDA involving unintended radiation emission—a high-risk hazard in medical devices. Although no reported illnesses or injuries are stated in the source text, the potential for patient harm from unintended radiation exposure during medical procedures justifies a High severity rating.
Plain-English summary
Philips North America LLC is recalling the Veradius Unity medical device (Product Code 718132), which is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures. The wireless foot switch pedal may become stuck in the active position when the user releases it, resulting in the emission of unintended radiation.
The device is used on patients of all ages except neonates (birth to one month). Healthcare facilities and clinicians using affected units should discontinue use and contact Philips for instructions on device replacement or repair. The recall applies to units distributed in the United States.
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
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.
Part of a larger recall action
This product is one of 3 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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