Z-0241-2026Class II

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

Name: Z-0241-2026 Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Creator: Philips Medical Systems Nederland B.v.
Published: 2025-09-29
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-09-29 / Open, Classified / root cause: manufacturing process

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system on 2025-09-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0241-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-29
Posted: 2025-10-23
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On September 29, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Circulate this notice to all users and follow the instructions in the letter. 2. Affected systems may continue to be used in accordance with their intended use and Instructions for Use (IFU). 3. Ensure the letter is in a place likely to be seen/viewed. 4. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 5. If you experience the issue described in this letter, please report it to your local Philips representative. Actions by Philips: Starting in October 2025, Philips will replace the 11W control board of the affected Zenition 50 systems. Your local Philips representative will contact you to schedule a visit to perform this activity in your system.
Quantity in commerce: 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.
Product codes and lots: Product Number (REF): 718096; UDI-DI: 00884838091535; All serial numbers;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0241-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0241-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23

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)