PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Device Recall

Recall Details

Recall Number

Z-0241-2026

Classification

Class II

Product Type

Device

Recalling Firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Status

Ongoing

Date Initiated

09/29/2025

Location

Best, Netherlands

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

29 units

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.

Product Description

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

Distribution Pattern

Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.

Other Recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

• Class II: Risk 12/15/2025
  Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
• Class II: Risk 12/15/2025
  Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
• Class II: Risk 12/15/2025
  Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
• Class II: Risk 12/15/2025
  Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
• Class II: Risk 12/15/2025
  Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

View all recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. →