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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00906-1
Product Name/Description GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor

Model Numbers:
01039717 – Right hinge EDS8-R and
01039716 – Left hinge EDS8-L

ARTG Number: 276061
(Getinge Australia Pty Ltd - Endoscope drying/storage chamber)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/07/2018
Responsible Entity Getinge Australia Pty Ltd
Reason/Issue Getinge have identified an issue which may result in a lack of drying/storage of restrictive endoscopes when they are placed in the EDS8.
This potential for malfunction is caused by a device design issue. It is identified that the delivered pressure and flow rate of the EDS8 compressor is too low. Under certain conditions (drying/storage of a restrictive endoscope), the compressor may not be powerful enough to reach the 5L/min airflow required to properly dry/store the endoscopes.

Getinge have received several complaints related to this issue, but there was no reported user or patient injury.
Recall Action Product Defect Correction
Recall Action Instructions Getinge have developed a compressor with a higher flowrate to correct this issue. Getinge will contact users to arrange replacement of the current compressor.

This action has been closed out on 15/08/2019
Contact Information 1800 438 464 - Getinge Customer Service