Recall Z-0854-2016— Philips Electronics North America Corporation

Name: FDA recall Z-0854-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-04

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-01-04, terminated 2021-03-01. It names one FDA 510(k) clearance: K150310. Product: Philips IntelliVue Module Measurement X2 Model: M3002A. Reason: The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor.

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-01-04
Terminated: 2021-03-01
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K150310 — IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH·cleared 2015-05-13

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

Philips IntelliVue Module Measurement X2 Model: M3002A

Reason for recall

The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor

Data sourced from openFDA. This site is unofficial and independent of the FDA.