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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