Philips IntelliVue MP2 Patient Monitors (865040) - Product… recallZ-0545-2021 · Philips North America Llc · initiated Nov 18, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0545-2021
- Status
- Terminated
- Initiated by the company
- Nov 18, 2020
- Recalling firm
- Philips North America Llc
- Quantity
- 2 units OUS
- Product code
- DSI
- FDA submissions
- K083517
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.
Product description
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.
Code information (models, lots, serial numbers)
Serial Numbers: DE73602213 DE73602577 UDI: (01)00884838000278(21)DE73602213 (01)00884838000278(21)DE73602577
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IntelliVue MP2 865040Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)2 recalls43 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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