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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01144-1
Product Name/Description DRX-1 System Console (radiation therapy digital imager)

All batch / serial numbers

ARTG Number: 161988
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 13/11/2012
Responsible Entity Carestream Health Australia Pty Ltd
Reason/Issue Carestream Health Australia has received advice that there is a remote possibility that the DRX-1 System console has reversed cable neutral and ground wires on the interface box appliance connector.
Recall Action Recall for Product Correction
Recall Action Instructions Carestream is advising end users not to use potentially affected devices until they have been inspected by their technicians and undergone corrections, if necessary.
Contact Information 02 9420 8963 - Carestream