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Visera imaging system – hysterovideoscope
Official notice
4 Aug 2023
Last checked
4 Aug 2023
An official Health Canada notice concerns Visera imaging system – hysterovideoscope. 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 Published 2023-08-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74065
Official notice
2023-08-04
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Olympus Medical, Visera Imaging System – Hysterovideoscope.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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