—#168916

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.

FDA product code: DSI — Detector And Alarm, Arrhythmia
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K113125
Affected lot / code info: All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)

Why it was recalled

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 (FDA determination)

Vendor change control

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2018-10-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168916. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.