Patient Information Center iX with Software Version Number 4 — Class II medical device recall Z-2608-2023
Ongoing recall by Philips North America Llc, reported 2023-09-27, distributed nationwide. Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with
| Recall number | Z-2608-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2023-08-17 |
| Classified | 2023-09-19 |
| Reported by FDA | 2023-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BH, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IN, IT, JO, JP, KE, KR, KW, LB, LT, NL, NO, PL, PT, QA, RO, SE, SK, ZA |
| Quantity | 960 units |
| UPC / GTIN / UDI-DI | 00884838104594, 00884838112070 |
Product
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essentials Expand Product Number: 867154
Reason for recall
Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients
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-2608-2023. 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.