Bronchovideoscope (2020-09-01)

Starting date:

September 1, 2020

Posting date:

September 18, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73929

Last updated:
2020-09-18

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  Reason
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  Affected products

Affected Products

Bronchovideoscope

Reason

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.

Affected products