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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00130-1
Product Name/Description OER-AW Endoscope Reprocessor

Impacted models of duodenoscopes: JF-20, JF-140F, TJF-M20, TJF-30, TJF-145, TJF-140F, TJF-150, TJF-160F, TJF-160VF and TJF-Q180V

ARTG Number: 185051
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 30/01/2017
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue There is an update of the Operation Manual for the OER-AW Endoscope Reprocessor to instruct users of non-detachable distal cover type duodenoscopes, such as the TJF-Q180V duodenoscope, to follow the pre-cleaning and manual cleaning as stated in the duodenoscope’s reprocessing manual prior to setting them into the OER-AW.

The following warning has been added to the List of Compatible Endoscopes/Connecting Tubes and Chapter 4 “Basic Endoscope Reprocessing Operations” of the OER-AW Operation Manual - "When reprocessing the following non-detachable distal cover type duodenoscopes using OER-AW, conduct pre-cleaning and manual cleaning as detailed in each duodenoscope’s reprocessing manual".
Recall Action Recall for Product Correction
Recall Action Instructions Olympus is requesting users to inspect their inventory and replace any existing OER-AW Operation Manuals and List of Compatible Endoscopes/Connecting Tubes with the latest version supplied.They are further advised to implement the instructions enclosed in the updated OER-AW Operation Manual. This action has been closed-out on 06/07/2017.
Contact Information 1300 657 699 - Olympus Customer Operations