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Health Canada Medical devices

Zenition 50

Issued October 15, 2025
Issue
Philips has been notified by a supplier about an issue affecting integrated chips used in the image intensifier television (IITV) of the Zenition 50 systems. Due to contamination in the bonding layer of the chips on the PCBA (printed circuit board assembly) there could be corrosion of the bonding layer, potentially resulting in intermittent or permanent connection loss of the integrated chips. The issue may result in loss of imaging functionality, or clinically unusable images due to reduced image quality (blurred, reduced image size).
Hazard description
Performance
Product
Product name
Zenition 50
Reference
ID
RA-78297