Recall Z-2328-2016 · MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Philips Electronics North America Corporation

IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by train

Date	Jul 26, 2016
Status	Terminated
Reason	If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.
Root cause	Nonconforming Material/Component
Action	Philips sent an Urgent Medical Device Correction letter dated July 20, 2016 to all affected customers. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Customers were informed that Philips will provide a software correction free of charge. For any further information or support concerning this issue, contact your local Philips representative at 1-800-722-9377.
Quantity	50,495
Distribution	Worldwide Distribution - US Nationwide
FDA record	Open on fda.gov

510(k) clearances named in this recall

K131872	INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Oct 17, 2013
K141015	INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, May 19, 2014
K161531	IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP Philips Medizin Systeme Boeblingen GmbH, Jul 1, 2016