Health product recall

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

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

Bronchovideoscope

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

BF-Q180

Companies
Manufacturer

Olympus Medical Systems Corp.

2951 Ishikawa-cho

Hachioji-shi, Tokyo

192-8507

JAPAN