Reported Apr 30, 2025 · Ongoing
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic,…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- 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.
- Lot codes and dates
- Product UDI(01)00884838091535(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, Wireless foot switch 3P, 459800415542, WFS Base Station
- Amount recalled
- N/A
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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