Philips IntelliVue X2 Multi measurement Server: M3002A — Class II medical device recall Z-0544-2021
Terminated recall by Philips North America Llc, reported 2020-12-16, distributed nationwide. Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP o
| Recall number | Z-0544-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2020-11-18 |
| Classified | 2020-12-08 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2021-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, DE, GB, HK, PT |
| Reason classes | device malfunction |
| Serial numbers | DE73601547, DE73601596, DE73601651, DE73601727, DE73604182, DE73604240, DE73607498, DE73607502, DE73608191, DE73608209, DE73608259, DE83617500, DE83617522, DE83617535, DE95038935 |
Product
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.
Reason for recall
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
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-0544-2021. 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.