| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00077-1 |
| Product Name/Description |
Philips IntelliVue Information Center (PIIC) iX system (A Centralized Patient Monitoring System)
Part Numbers: 866023 (IntelliVue Info Center iX), 866024 (PIIC iX Upgrade), 866117 (PIIC Classic Upgrade)
Serial Numbers: Release A.00, A.01 and A.02 versions in use with M4841A/TRx4851 telemetry devices
ARTG Number: 94237 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Philips is informing that a software defect has been identified that involves the use of the “Change Bed Label” feature at the Information Center iX. If the configuration for this item is set to “optional” and a user selects the “Location” button within the “Manage Patient” menu and makes a change to the patient
location, alarms for Sp02 and/or Non Invasive Blood Pressure (NBP) will become disabled without visual notification (bell with an “X”) to the user. This problem only happens when the patient is monitored using a networked IntelliVue TRx Telemetry M4841/TRx4851A Patient Worn Device (PWD). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing instructions to the users to prevent this issue from occurring:
Customers/users should:
1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing the feature from ‘Optional to ‘Hidden’
2) All patient transfers must be performed using the Transfer key in the Manage Patient application.
Philips is providing a software correction to customers with impacted devices at no charge. This action has been closed-out on 08/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |