Product Wiki · Recalls · Health Canada — Medical Devices

Bronchovideoscope (2020-09-01) — recall 61608

Health Canada — Medical Devices · Canada · 2020-09-18 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61608
Date of alert
2020-09-18
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Olympus Medical Systems Corporation (OMSC) performed a postmarket risk assessment of the BF-Q180, including adverse events review, which showed that the BF-Q180 is associated with a higher rate of patient infections than other comparable OMSC Bronchoscopes. While this rate of infection is low (less than 0.01%), and patient infection rates depend on a number of factors, out of an abundance of caution and to minimize to the fullest extent possible the risk of infection, OMSC has begun a worldwide transition of the BF-Q180 to newer, similarly indicated Bronchoscope Models.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bronchovideoscope-2020-09-01

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