—#184681

Product

Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.

FDA product code: DSI — Detector And Alarm, Arrhythmia
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K083517
Affected lot / code info: Serial Numbers: DE73602213 DE73602577 UDI: (01)00884838000278(21)DE73602213 (01)00884838000278(21)DE73602577

Why it was recalled

Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

Root cause (FDA determination)

Process control

Action the firm took

Philips North America issued Customer notifications on 11/18/2020 to US customers, via priority mail. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Philips is asking users to follow the Action to be Taken by Customer/User section of the FSN: Affected products may continue to be used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the Speaker Malfunct. INOP at power-up. If you experience this INOP or there is no sound from your X2 / MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative Philips representative or Philips Customer Support at 1-800-722-9377 Please complete the attached Reply Card and return it to Philips as soon as possible. Philips will replace affected speaker assemblies free of charge. A Philips Healthcare representative will contact you to arrange for the replacement of the speaker assembly in the listed affected devices.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.

Timeline

Recall initiated: 2020-11-18
Terminated: 2021-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184681. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.