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Health Canada Medical devices

Pentax Medical Video Processor

Issued August 7, 2025
Issue
Under certain conditions during endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark. While we have not received reports of any serious incidents, some have observed steam-like vaporization and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, which may pose a risk to patients. Recall start date: August 4, 2025
Hazard description
Performance
Product
Product name
Pentax Medical Video Processor
Reference
ID
RA-77816