| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00259-1 |
| Product Name/Description |
Philips IntelliVue Information Center iX (PIIC iX) software release A.01.XX (Central patient monitoring station)
ARTG Number: 94237 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Philips has received a customer report that the PIIC iX (release A.01.XX) central stations that are connected to a database server (DBS) may not be able to complete a restart/reboot resulting in the loss of central monitoring. This defect occurs when the following two criteria are met:
1. The workflow for reviewing stored patient data on the PIIC iX involves the modification of the default trend scales in the retrospective review applications and these trend scales are customised for hundreds of different patients (within a period of seven days or less); and
2. A planned/unplanned event resulting in the restart/reboot of the PIIC iX central stations (e.g. Deliberate reboot, network connection to the DBS is lost and PIIC central stations go into local mode, power failure, etc.). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are provided with instructions to prevent the defect from occurring. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of updated PIIC iX software, resolving this issue on all affected units. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |