Recall Z-0035-2025 ยท DSI Detector And Alarm, Arrhythmia
Philips North America
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
| Date | Oct 8, 2024 (initiated Apr 19, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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: |
| Quantity | 591 devices |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |