Health product recall

Pentax Medical Video Processor

Brand(s)
Last updated

Summary

Product
Pentax Medical Video Processor
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Pentax Medical Video Processor Not 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Hoya Corporation
6-10-1 Nishi-Shinjuku, Tokyo, Tokyo-To, Japan, 160-0023
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77816

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