FDA recall Z-0292-2018

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 for recall

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

Distribution

Worldwide Distribution and US Nationwide

Key facts

Status

Ongoing

Initiation date

2017-08-23

Report date

2018-01-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0292-2018