Visera Imaging System – Hysterovideoscope
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
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