| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00070-1 |
| Product Name/Description |
MultiDiagnost Eleva Flat Detector (FD) System
(Diagnostic fluoroscopic digital X-ray system)
Product Code: 708037
ARTG Number: 98560 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect. In the MD Eleva system, software license keys are used to enable particular functionality. In software release R6.1.1sp2 and R6.1.2 intermittently part of the software keys are not loaded:
- the license key for spectral filter
- the license key for full table tilt range |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is recommending a system restart that may solve both issues when the software keys are not loaded.
Philips Healthcare is providing the following instructions to identify the defects:
If the license key for spectral filter is not loaded: once an EPX with half-dose is selected the incomplete dose reduction can be noticed via the actual skin dose (rate) displayed on the image monitor and the actual filter selection is displayed on the examination monitor.
If the license key for full table tilt range is not loaded: The tilt movement stops at -20 degrees. This can be observed while preparing the room.
Philips Healthcare released a software update and organising Philips field service engineers to install Software release R6.1.3 which addresses the non-loading of the Software license keys. This action has been closed-out on 08/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |