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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00474-1
Product Name/Description Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411

ARTG Number 178856
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 2/06/2015
Responsible Entity AGFA HealthCare Australia
Reason/Issue 1) When using the DX-D 100 unit, sporadic unintended movements may be caused by an electrostatic discharge of the unit to the ground may occur.

2) Capacitive touch screens rely on the electrical properties of the human body to enable you to operate the device with very light touches of a finger. However, when liquid comes in contact with the touch screen it may incorrectly recognize this as user input. This issue was notified to users previously (TGA ref:. RC-2014-RN-00674-1). A software fix to mitigate this issue will be implemented as part of this action.
Recall Action Recall for Product Correction
Recall Action Instructions 1) A newly designed arrestor with a resistance of 1M ohm between frame and floor (ground) will be installed. Together with an update of Digital Motion Control (DMC) firmware this will prevent sporadic unintended movements. In the interim, users are advised that the unit is equipped with a safety switch in the drive handle and in case of an unintended movement, they should release the drive handle and the unit will stop.

2) A software update to change the behaviour of the touch screen so that holding the up or down button will change the value setting just a single step will limit the influence of an unintentional touch screen activation. In the interim, the operator must make sure that both hands and the touch screen are dry before utilizing the touch screen. The operator always should double check and verify the selected parameters and settings immediately before making an exposure (Ref. former letter (TGA ref:. RC-2014-RN-00674-1) and/or User Manual addendum communication). This action has been closed-out on 19/08/2016.
Contact Information 1300 364 612 Service Help Desk