| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01297-1 |
| Product Name/Description |
Philips IntelliVue MX40 Patient Wearable Monitor s/w versions B.05.28, B.05.29 and B.05.32
Product Numbers: 865351, 865352
Exchange Part Numbers: 453564262531, 453564262551, 453564262571, 453564262591, 453564615351, 453564615371
Product number and Exchange part number (identified as Service #) are displayed on the devices product label located on the back of the device
ARTG Number: 99204 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
When the local "Alarms On" configuration setting on the Phillips IntelliVue MX40 Patient Wearable Monitor is modified from its factory default, in certain software revisions, it will disable generation and delivery of ECG alarms to the Philips IntelliVue Information Center iX (PIIC iX) without a visual indication on the PIIC iX that the ECG alarms have been disabled. If the generation and delivery of ECG alarms to the Information Center is disabled without a corresponding visual indication at the Information Center, a delay in treatment could occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Phillips is implementing software upgrade for affected Phillips IntelliVue MX40 Patient Wearable Monitors. Users with affected devices will be contacted by a Phillips Healthcare representative for the installation of the software upgrade. In the interim, users are advised to make sure that the MX40 Patient Wearable Monitor local configuration setting ‘Alarms On’ is configured to its factory default. Philips is providing instructions to change the local configuration settings in the customer letter.
This action has been closed-out on 21/03/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |