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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