| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01208-1 |
| Product Name/Description |
DigitalDiagnost (Digital diagnostic X-Ray System) with software version 2.0.2 and 2.0.2SP1
All products with software release 2.0.2 and 2.0.2SP1
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Philips previously notified owners of affected DigitalDiagnost systems that software release 2.1.3 would be installed on the systems to modify the
appearance of a mirror icon. However, software release 2.1.3 contained a defect that may result in the incorrect placement of the
electronic marker (left/right) indicating the patient side if an image is rotated.
Software release 2.1.4 addresses both the original & new issue, & it will be installed on affected systems in place of release 2.1.3. If software release
2.1.3 has already been installed on a system, it will be replaced with release 2.1.4.
With DigitalDiagnost R 2.0.2 a mirrored “R in a circle” is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is
mirrored back inside the PACS system, an unmirrored “R in a circle” appears in the lower left corner. This can be mistaken for a “right patient side” marker,
although this can appear on the left patient side. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare will be installing a software update to address the identified issue. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |