| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01200-1 |
| Product Name/Description |
DigitalDiagnost (Digital diagnostic X-Ray System) All systems with Eleva software version 2.1.3
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
When the operator for a wall stand view selects an 'image rotation' different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers to implement the work-around provided by the sponsor until the software update has been completed. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |