Public recall detail

Pentax Medical Video Processors

2025-02-28

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Recall Safety notice
Quick summary

Quick summary: Pentax Medical Video Processors . Date: 2025-02-28.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Pentax Medical Video Processors . Date: 2025-02-28.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandHoya Corporation
ProductPentax Medical Video Processors
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77039

Affected products

ProductPentax Medical Video Processor
LotAll lots.
ModelEPK-I8020C
Serial numberAll lots.
DescriptionPentax Medical Video Processor
ProductPentax Medical Video Colonoscope
LotAll lots.
ModelEC38-I20CL EC34-I20CL EC38-I20CWL
Serial numberAll lots.
DescriptionPentax Medical Video Colonoscope
ProductPentax Medical Video Upper GI Scope
LotAll lots.
ModelEG27-I20C EG29-I20C
Serial numberAll lots.
DescriptionPentax Medical Video Upper GI Scope

Issue

Under certain conditions, during endoscopic procedures using a combination of the Pentax Medical Video Processor EPK-I8020C and the Pentax Medical Video Upper GI Scope EG29-I20C, the observed image can become reddish or dark. Globally, Pentax has received 32 complaints related to this issue. The users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes. These phenomena occur when substances such as mucus and blood attached to the light guide (illumination part) at the distal end of the endoscope absorb the illumination light from the light source to the maximum extent, causing it to heat up and coagulate. They are more likely to occur in OE (optical enhancement) mode but have also been observed with white light. Although the existing instructions for use already include cautionary statements to contemplate the risk of harm observed, Pentax Medical is issuing this customer communication to further reduce the potential health risk. Recall start date: February 18, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesHoya Corporation 6-10-1 Nishi-Shinjuku, Tokyo, Tokyo-To, Japan, 160-0023
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77039
Background{}
CompaniesHoya Corporation 6-10-1 Nishi-Shinjuku, Tokyo, Tokyo-To, Japan, 160-0023
AudiencesHealthcare
Source updated2025-02-28

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