Health product recall

Visera Imaging System – Hysterovideoscope

Last updated

Summary

Product
Visera Imaging System – Hysterovideoscope
Issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Visera Imaging System – Hysterovideoscope

More than 10 numbers, contact manufacturer.

HYF-V

Issue

Manufacturer notification to highlight the following changes:
1. Change conditions for ethylene oxide (EtO) gas sterilization from 12% EtO to 100% EtO.
2. Reusable cleaning brush are no longer compatible for the manual cleaning. single use brushes remain compatible and are the recommended choice.

Insufficient reprocessing, potentially resulting in contamination with/without subsequent infection, may result when device is utilized in medical procedures where the end user (health care facility) has not implemented these newly revised instructions for use.

Recall start date: July 24, 2023

Additional information

Details
Original published date: 2023-08-04
Alert / recall type
Health product recall
Category
Health products - Medical devices - Obstetrics and gynaecology
Companies

Olympus Medical Systems Corp.

2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74065