FDA Device recall Z-0292-2018
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient M…
- FDA Device
- Class II
- ongoing
- Published 2018-01-03
On 2018-01-03 the FDA classified a Class II recall of IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient M… by Philips Electronics North America, citing distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0292-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-08-23 |
| Published | 2018-01-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.
Reason
Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors
Identifiers
| code_info | Model #: M300IA/AL, M3002A, M8102A, M8105A with ECO FW revision E.0 1.22 and 12-lead option C#12 Lots #s included on C…Model #: M300IA/AL, M3002A, M8102A, M8105A with ECO FW revision E.0 1.22 and 12-lead option C#12 Lots #s included on Consignee list Catalog #: 862442 (M3001A), 866462 (M3001AL), 865039 (M3002A), 865040 (M8102A), 865024 (M8105A) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0292-2018%22
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