Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, i
Summary
The FDA issued a Class II for Zenition 50. Product Code 718096. The devices are used for radiological guidanc by Philips North America Llc. Reason: 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.
Details
Source
Device Recall
External ID
Z-1580-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
Product Description
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/Code Info: 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
Quantity Affected: N/A
Reason for Recall
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.
Distribution
US
Type: FDA Mandated
Recall Initiated: 2025-02-25
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1580-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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