Automated Endoscope Reprocessor (2019-02-19)

Starting date:

February 19, 2019

Posting date:

March 15, 2019

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-69284

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  Reason
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  Affected products

Affected Products

Automated Endoscope Reprocessor

Reason

Olympus Medical Systems Corp has revised the OER-Pro labeling to remove high level disinfection as a suitable reprocessing method for certain models of ureteroscope (URF-V2, URF-V2R, URF-P6 and URF-P6R). Olympus previously notified customers of these ureteroscopes about the change in reprocessing methods in a separate recall. To align with the change, Olympus Medical Systems Corp has updated the following labelling for the OER-Pro:

1. reference guide entitled 'List of Compatible Endoscopes/Connecting Tubes for the OERPro'
2. label located on the OER-Pro unit label entitled 'Endoscope Combinations for Dual Scope Reprocessing'.

Affected products