Health product recall

Olympus Bronchovideoscopes

Last updated

Summary

Product
Olympus Bronchovideoscopes
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
EVIS EXERA III Video System - Bronchovideoscope More than 10 numbers, contact manufacturer. BF-XT190
EVIS EXERA III Video System - Bronchovideoscope More than 10 numbers, contact manufacturer. BF-P190
EVIS EXERA III Video System - Bronchovideoscope More than 10 numbers, contact manufacturer. BF-1TH190
EVIS EXERA III Video System - Bronchovideoscope More than 10 numbers, contact manufacturer. BF-H190
EVIS EXERA III Video System - Bronchovideoscope More than 10 numbers, contact manufacturer. BF-Q190
Bronchovideoscope More than 10 numbers, contact manufacturer. BF-1TH1100
Bronchovideoscope More than 10 numbers, contact manufacturer. BF-H1100
EVIS EXERA Video Sytem - Bronchovideoscope More than 10 numbers, contact manufacturer. BF-XT160
OES Bronchofiberscopes More than 10 numbers, contact manufacturer. BF-P60
OES Bronchofiberscopes More than 10 numbers, contact manufacturer. BF-1T60
OES Bronchofiberscopes More than 10 numbers, contact manufacturer. BF-XT40
OES Bronchofiberscopes More than 10 numbers, contact manufacturer. BF-MP60
Evis Exera II Video System - Bronchovideoscopes More than 10 numbers, contact manufacturer. BF-1TQ180
Evis Exera II Video System - Bronchovideoscopes More than 10 numbers, contact manufacturer. BF-P180
Evis Exera II Video System - Bronchovideoscopes More than 10 numbers, contact manufacturer. BF-Q180-AC
Evis Exera II Video System - Bronchovideoscopes More than 10 numbers, contact manufacturer. BF-Q180
Evis Exera II Video System - Bronchovideoscopes More than 10 numbers, contact manufacturer. BF-1T180

Issue

Olympus has determined that additional IFU updates are necessary to provide further clarification on safe and effective use of the bronchoscopes when used in conjunction with laser, argon plasma coagulation, and highfrequency therapy equipment. Users should obtain the updated IFU through Olympus Canada Technical Assistance Center (TAC).

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 and urology
Companies
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Recall date
Identification number
RA-78067

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