Health product recall

EVIS EXERA Bronchovideoscopes

Last updated

Summary

Product
EVIS EXERA Bronchovideoscopes
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

EVIS EXERA Video System - Bronchovideoscope

All lots.

BF-3C160

EVIS EXERA II Video System - Bronchovideoscopes

All lots.

BF-1TQ180
BF-P180
BF-Q180-AC
BF-1T180

EVIS EXERA III Video System - Bronchovideoscopes

All lots.

BF-XT190
BF-P190
BF-MP190F
BF-1TH190
BF-H190
BF-Q190
BF-XP190

EVIS EUS Ultrasound Bronchofibervideoscope

All lots.

BF-UC190F

EVIS EXERA III Ultrasonic Bronchofibervideoscope

All lots.

BF-UC180F

Issue

Olympus has received four (4) adverse event complaints of endobronchial combustion during therapeutic procedures with the Olympus bronchoscope model BF-XT190, of which one (1) involved high-frequency therapy equipment. the other three (3) adverse events involved unknown energy therapy equipment. There are a total of 28 models of the BF series endoscopes that can be used in combination with high-frequency therapy equipment

Recall start date: October 27, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Health products - Medical devices - Gastroenterology & Urology
Health products - Medical devices - General and plastic surgery
Companies

Olympus Medical Systems Corp.

2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74619

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