Z-0592-2019Class II

IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 -

Name: Z-0592-2019 IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 -
Creator: Philips Electronics North America Corporation
Published: 2018-10-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-10-10 / Open, Classified / root cause: supplier

FDA source

Philips Electronics North America Corporation began a recall of IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a... on 2018-10-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0592-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-10-10
Posted: 2018-12-10
Recalling firm: Philips North America LLC
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.
Product code: DSI Detector And Alarm, Arrhythmia
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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On November 9, 2018, the firm notified customers of the issue via Customer Information Letters. The letter discussed the product problem. Customers are asked to confirm speaker behavior. It is recommended that the clinical user reboot the MX40 prior to entering Monitoring Mode to confirm proper operation of the speaker. Customers are also asked to complete the attached Reply Card and return to Philips as soon as possible. The firm will replace affected devices used at above 4,500 feet (1,372 meters). If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.
Quantity in commerce: 35469 units
Distribution: US Nationwide distribution.
Product codes and lots: All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0592-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0592-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-19	2018-12-10

Product code DSI

K113125Class IIIntellivue Mx40 Patient MonitorPhilips Medical Systems / cleared 2011-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)