Zenition recallZ-1581-2025 · Philips North America Llc · initiated Feb 25, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Labeling design
What the company is doing
Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide the actions that should be taken in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. Philips proposes sending the Electronic Product Radiation Defect notification to customers immediately upon FDA approval of the corrective action plan, and completion of the remaining activities within 4 months of FDA approval of the corrective action plan. This corrective action does not require any customer transportation reimbursement. The following statement is included in the customer communication: The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. Draft of letter provided. Philips commits to notifying the FDA on a monthly basis providing progress with this field correction.
Recall details
- Recall number
- Z-1581-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 25, 2025
- Posted by the FDA
- Apr 21, 2025
- Recalling firm
- Philips North America Llc
- Product code
- OWB
- FDA submissions
- K183040, K212813
- Distribution
- US
Product description
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.
Code information (models, lots, serial numbers)
Product UDI: (01)00884838091528(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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zenition Zenition 70Philips Medical Systems Nederland B.V. · Image-Intensified Fluoroscopic X-Ray System, Mobile2 recalls80 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96593).
- Z-1580-2025 · Open, ClassifiedZenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except…
- Z-1582-2025 · Open, ClassifiedVeradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, exc…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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