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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00001-1
Product Name/Description	Runyes Autoclave 17L, 22L B Class Manufactured between 2012 & 2017 Multiple Serial Numbers ARTG Number: 197900 (Medical Equipment Australia Pty Ltd - Sterilizer, moist heat, fluid)
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	12/01/2018
Responsible Entity	Medical Equipment Australia Pty Ltd
Reason/Issue	Medical Equipment Australia has been made aware of an issue regarding the failure of cycles when the negative pressure is not within a specified range. Affected devices will be provided with a software update to rectify the issue of monitoring critical parameters during a cycle and generate a 'fail' if they are not reached.
Recall Action	Recall for Product Correction
Recall Action Instructions	Medical Equipment Australia will arrange a service technician to be in contact with users to arrange for software upgrade to correct this issue. In the interim, users should refer to the tests outlined in the customer letter to verify that their equipment is functioning correctly. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	03 9331 6796 - Medical Equipment Australia