Patient Information Center iX — Class II medical device recall Z-0035-2025
Ongoing recall by Philips North America, reported 2024-10-16, distributed nationwide. During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease ca
| Recall number | Z-0035-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-04-19 |
| Classified | 2024-10-08 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 591 devices |
| UPC / GTIN / UDI-DI | 00884838104594 |
| Serial numbers | 003W-3UN7-M, 007B-4EJH-V, 0106-0UH7-D, 0169-1PJ5-P, 016X-52P8-4, 017L-0VKT-B, 0214-0MNA-L, 021Z-1WJ2-5, 024J-7WMK-3, 027J-7LPC-9, 0302-5TLL-M, 0439-16GM-G, 057M-7JG6-U, 061T-7TJA-R, 062U-1VNP-B, 065K-5AGH-N, 067T-5FNJ-E, 073G-46MR-H, 077H-7LPC-9, 077M-7JG6-L, 0802-71KX-C, 084H-1CJJ-A, 0856-68PX-Z, 085D-5VMH-8, 087H-7LPC-6 and 475 more |
Product
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0035-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.