FDAClass IIOctober 29, 2025

Zenition 50 recall

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

Why was Zenition 50 recalled?

Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;

Product
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity
29 units
Distribution
Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
Recall date
October 29, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls