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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00208-1
Product Name/Description IMRIS ORT100 and ORT300 Operating Room Tables

Part Numbers: 110470-000 and 114093-000

Serial Numbers: 10003241 and 10002255

ARTG Number: 276861
(Emergo Asia Pacific T/a Emergo Australia - Table, x-ray system, diagnostic, general-purpose, powered)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 21/03/2018
Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue The ORT100 and ORT300 tables may drift while in use, which could potentially result in unintended movement of the table. The drift occurs slowly over time and typically is not recognised until after several hours.
There have been two reports of injury overseas as a result of this issue.
Recall Action Product Defect Correction
Recall Action Instructions Emergo is advising that the following corrective actions will be undertaken:
ยท ORT100: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do no pass the drift test, a hydraulic fluid flush and filter change will be performed.
ยท ORT300: All customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed. A drift test will also be performed.

This action has been closed out on the 26/11/2018.
Contact Information 02 9006 1662 - Emergo Australia