Recall Monitor
Health Products

Pentax Medical Video Processor

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Pentax Medical Video Processor
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Pentax Medical Video ProcessorNot applicable.EPK-i8020c

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

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