| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00069-1 |
| Product Name/Description |
MultiDiagnost Eleva II/TV Systems
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 accordance with 21 CFR 1003.2(b)(1). 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 is providing end users with instruction on how to identify if the drivers are not loading correctly. A Philips Field Service Engineer will install a software update to correct this issue. This action has been closed-out on 31/05/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |