IntelliVue X3 Patient Monitor — Class II medical device recall Z-1315-2018
Terminated recall by Philips Electronics North America Corporation, reported 2018-04-18. The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the dias
| Recall number | Z-1315-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2017-11-17 |
| Classified | 2018-04-06 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2020-09-16 |
| Serial numbers | DE61100100, DE61100101, DE61100102, DE61100103, DE61100104, DE61100106, DE61100107, DE61100109, DE61100110, DE61100111, DE61100113, DE61100114, DE61100115, DE61100116, DE61100117, DE61100118, DE61100119, DE61100120, DE61100121, DE61100122, DE61100123, DE61100124, DE61100125, DE61100127, DE61100128 and 475 more |
| Model numbers | 867030 |
Product
IntelliVue X3 Patient Monitor.
Reason for recall
The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.
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-1315-2018. 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.