Recall Z-0592-2019— Philips Electronics North America Corporation

Name: FDA recall Z-0592-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-10

Class II · Ongoing

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2018-10-10. It names one FDA 510(k) clearance: K113125. Product: IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.. Reason: A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Ongoing
Initiated: 2018-10-10
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K113125 — INTELLIVUE MX40 PATIENT MONITORPhilips Medical Systems·cleared 2011-11-17

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 MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Reason for recall

A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet.

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