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Open, Classified

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.

FDA Recall Z-0292-2018 · Posted None

Recalling FirmPhilips Electronics North America Corporation
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2017-08-23
Product Quantity7071

Reason for Recall

Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors

Firm Action

Philips sent an Urgent Medical Device Correction letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips will provide software update and is provding interim instructions for the operator. For questions contact your local Philips representative.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution and US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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