FDA Device recall Z-0544-2021
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate…
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate… by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0544-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-18 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: US: DE73607502 DE73607498 OUS: System Serial Number DE95038935 DE73608191 DE73608209 DE7360…Serial Numbers: US: DE73607502 DE73607498 OUS: System Serial Number DE95038935 DE73608191 DE73608209 DE73601727 DE73604240 DE73601547 DE73601596 DE73604182 DE83617535 DE73608259 DE83617500 DE83617522 DE73601651 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0544-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.