Recall MonitorHealth ProductsType I recall
Olympus Bronchovideoscopes
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Ear, nose and throat, Health products - Medical devices - Gastroenterology and urology
Product: Olympus Bronchovideoscopes
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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).