Health product recall

Olympus Endoscopes

Last updated

Summary

Product
Olympus Endoscopes
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

Rhino-Laryngo Fiberscopes

More than 10 numbers, contact manufacturer.

ENF-T3

Oes Cystonephrofiberscopes

More than 10 numbers, contact manufacturer.

CYF-5

Evis Exera Ii Video System - Gastrointestinal Videoscopes Hd

More than 10 numbers, contact manufacturer.

GIF-2TH180
GIF-H180

Evis Exera Ii Video System - Colonovideoscopes Hd

More than 10 numbers, contact manufacturer.

PCF-H180AL
CF-H180AL
CF-H180DI
CF-H180DL

Gastrointestinal Videoscope

More than 10 numbers, contact manufacturer.

GIF-1100
GIF-H180J
GIF-XP180N

Visera Imaging System - Transnasal Esophagovideoscope

More than 10 numbers, contact manufacturer.

PEF-V

Visera Imaging System - Tracheal Intubation Videoscope

More than 10 numbers, contact manufacturer.

LF-V

Evis Exera Iii Video System - Bronchovideoscope

More than 10 numbers, contact manufacturer.

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

Airway Mobilescope

More than 10 numbers, contact manufacturer.

MAF-DM2
MAF-GM2

Airway Mobilescope

More than 10 numbers, contact manufacturer.

MAF-TM2

Oes Hysterofiberscopes

More than 10 numbers, contact manufacturer.

HYF-XP
HYF-1T

Evis Exera Ii Video System - Bronchovideoscopes

More than 10 numbers, contact manufacturer.

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

Evis Exera Ii Video System - Small Intestinal Videoscope

More than 10 numbers, contact manufacturer.

SIF-Q180

Duodenovideoscope

More than 10 numbers, contact manufacturer.

TJF-Q180V

Evis Exera Video Sytem - Bronchovideoscope

More than 10 numbers, contact manufacturer.

BF-3C160
BF-XT160

Oes Bronchofiberscopes

More than 10 numbers, contact manufacturer.

BF-XP60
BF-3C40

Oes Choledochofiberscopes

More than 10 numbers, contact manufacturer.

CHF-P60
CHF-BP30

Evis Exera Ii Ultrasonic Bronchofibervideoscope

More than 10 numbers, contact manufacturer.

BF-UC180F

Visera Imaging System- Cysto-Nephro Videoscope

More than 10 numbers, contact manufacturer.

CYF-V2

Evis Exera Iii Video System - Gastrointestinal Videoscope

More than 10 numbers, contact manufacturer.

GIF-XP190N
GIF-1TH190
GIF-HQ190
GIF-H190

Uretero-Reno Fiberscope

More than 10 numbers, contact manufacturer.

URF-P6
URF-P7R
URF-P6R
URF-P7

Evis Exera Video System - Bronchofibervideoscopes

More than 10 numbers, contact manufacturer.

BF-MP160F
BF-XP160F

Evis Exera Ii Ultrasound Gastrovideoscope

More than 10 numbers, contact manufacturer.

GF-UCT180

Cysto-Nephro Videoscope

More than 10 numbers, contact manufacturer.

CYF-VHR
CYF-VHA
CYF-VH

Evis Exera Iii Video System - Colonovideoscope

More than 10 numbers, contact manufacturer.

PCF-H190TL
PCF-HQ190L
CF-H190I
CF-HQ190L
PCF-H190DL
PCF-H190I
PCF-PH190L
CF-H190L
PCF-H190L
PCF-H190DI
PCF-HQ190I
CF-HQ190I
PCF-H190TI
PCF-PH190I

Evis Exera Video System - Sigmoidovideoscope

More than 10 numbers, contact manufacturer.

CF-Q160S

Airway Mobilescope - Therapeutic

More than 10 numbers, contact manufacturer.

MAF-TM

Olympus Ultrasonic Gastrovideoscopes For Aloka Ultrasound Processors

More than 10 numbers, contact manufacturer.

GF-UE160-AL5
GF-UC140P-AL5

Evis Exera Ii Video System - Colonovideoscopes

More than 10 numbers, contact manufacturer.

CF-Q180AL
PCF-Q180AL
PCF-Q180AI
Q180AI

Visera Video Rhino - Laryngoscope

More than 10 numbers, contact manufacturer.

ENF-VT2

Airway Mobilescope - General

More than 10 numbers, contact manufacturer.

MAF-GM

Evis Exera Iii Bronchofibervideoscope

More than 10 numbers, contact manufacturer.

BF-MP190F

Evis Exera Iii Duodenovideoscope

More than 10 numbers, contact manufacturer.

TJF-Q190V

Tracheal Intubation Fiberscopes

More than 10 numbers, contact manufacturer.

LF-DP
LF-GP
LF-TP

Vis Exera Ii Video System - Gastrovideoscopes

More than 10 numbers, contact manufacturer.

GIF-Q180
GIF-N180

Visera Imaging System - Hysterovideoscope

More than 10 numbers, contact manufacturer.

HYF-V

Oes Sigmoidofiberscopes

More than 10 numbers, contact manufacturer.

PCF-S

Rhino-Laryngo Videoscope

More than 10 numbers, contact manufacturer.

ENF-VT3

Uretero-Reno Videoscope

More than 10 numbers, contact manufacturer.

URF-V2R
URF-V
URF-V3R
URF-V2
URF-V3

Evis Exera Video System - Gastrovideoscopes

More than 10 numbers, contact manufacturer.

GIF-2T160
GIF-XTQ160
GIF-1TQ160
GIF-XP160
GIF-Q160Z

Evis Exera Video System - Colonovideoscope

More than 10 numbers, contact manufacturer.

CF-2T160L
CF-Q160ZL

Colonovideoscope

More than 10 numbers, contact manufacturer.

CF-HQ1100DI
CF-HQ1100DL

Issue

Following repair activities, Olympus uses a water flush of endoscope channels as part of our final endoscope channel inspection, and we subsequently dry the endoscope channels with compressed filtered air. Olympus discovered that our channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel.

Recall start date: September 25, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Ear, nose and throat
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - Obstetrics and gynaecology
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-74425

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