Philips IntelliVue Information Center iX — Class II medical device recall Z-0374-2016
Terminated recall by Philips Medical Systems, Inc., reported 2015-12-16, distributed nationwide. Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
| Recall number | Z-0374-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-12-04 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2020-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, DE, DK, EE, ES, FI, FR, GB, HU, IE, IL, IN, IQ, IS, IT, JP, LU, MA, NG, NL, NO, NZ, PL, PT, QA, RO, SE, SG, SI, TW, ZA |
| Quantity | 10,013 units |
Product
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Reason for recall
Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification
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-0374-2016. 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.