Recall Z-0292-2018— Philips Electronics North America Corporation
Class II · Ongoing
Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-08-23. It names 2 FDA 510(k) clearances: K150975, K150310. 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.
- Recalling firm
- Philips Electronics North America Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-08-23
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K150975 — Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors
- K150310 — IntelliVue Patient Monitor
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.