| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00674-1 |
| Product Name/Description |
DX-D 100 Digital Radiography X-Ray System
All Units
ARTG Number: 178856 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognise this as user input altering device settings. Capacitive touch screens rely on the electrical properties of the human body to enable users to operate the device with very light touches of a finger. However, when liquid comes in contact with the touch screen it may incorrectly recognise this as user input. For example, it could unexpectedly change the exposure settings. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that they must ensure their hands are dry before using the touch screen of the DX-D 100 because liquid residue may activate the action buttons on the touch screen. The following advice is provided in the customer letter in addition to referring users to the warning in the user manual::
- Do not operate touch screen monitor with wet hands.
- Do not let liquids come in contact with the touch screen while the DXD 100 is powered on.
- Always double check your parameter settings prior to exposing the patient. |
| Contact Information |
1300 364 612 - Agfa HealthCare Service Help Desk |