Z-1580-2025Class II

Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during...

Name: Z-1580-2025 Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during...
Creator: Philips North America Llc
Published: 2025-02-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-02-25 / Open, Classified / root cause: labeling and UDI

FDA source

Philips North America Llc began a recall of Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on... on 2025-02-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1580-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-25
Posted: 2025-04-21
Recalling firm: Philips North America LLC
Product: 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Distribution: US
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1580-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1580-2025	Class II	Ongoing	FDA Mandated	2025-04-30	2025-04-21
Z-1581-2025	Class II	Ongoing	FDA Mandated	2025-04-30	2025-04-21
Z-1582-2025	Class II	Ongoing	FDA Mandated	2025-04-30	2025-04-21

Product code OWB

K183101Class IIZenition 50Philips Medical Systems Nederland B.V. / cleared 2018-12-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)