Philips North America Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.

Recommended Action

Per FDA guidance

An IMPORTANT PRODUCT NOTICE dated 4/19/23 was sent to customers. The actions that you as a customer can take to minimize the effect of the problem This communication should be shared with all clinical staff to review and understand. Place this Important Product Notice with the documentation of the PIC iX Instructions for Use. Additional Actions Dependent on Normal Workflow: 1. Workf/ow A: MX40 Routinely Cleared from Sector: If the MX40 is routinely cleared from the sector upon discharge of a patient then no additional action is required. 2. Workflow B: MX40 not Routinely Cleared from Sector: Option 1: Change Default Settings to Clear Sector Automatically The PIC iX can be setup to routinely clear the sector by executing the following: a. This can be set as the default as needed by selecting the "Clear Sector" selection and the "Clear unlocked Telemetry Devices from bed" in the "Configuration, Patient Management/Workflow", as highlighted in the image below: Option 2: Clear MX40 from Sector Manually The MX40 can be cleared from the sector manually by following the steps below: a. Identify the sector to be cleared from the PIC iX. These steps may be repeated for all sectors in use if they are not routinely cleared. b. Select the "Manage Patient" button and the "Manage Patient" window will display. c. Select the "Clear Sector'' button and the discharge window will display. d. Check the box next to the "Clear Sector'' option, as shown in the example Image 4 below: e. Selecting the "Cancel" button does not change the sector assignment. Finalize the process by selecting the " Discharge" button. 3. Workflow C: Clear Sector Option Not Available: In some configurations, the clear sector function will not be available. If this occurs, please contact the local response center for guidance on how to proceed. 4. The actions planned by Philips to correct the problem A Philips representative will reach out to you to arrange for a software upgrade to your device. This upgrade wi