Events

Recall of IntelliVue MX40 Patient Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75209
  • Event Risk Class
    Class 2
  • Event Number
    Z-0291-2017
  • Event Initiated Date
    2016-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149668
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Philips intellivue mx40 patient wearable monitor configuration setting disables generation and delivery of ecg alarms to piic ix.
  • Action
    The firm, Philips Healthcare, sent a "Field Safety Notice (FSN)" dated 9/14/2016 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make sure that the MX40 Patient Wearable Monitor local configuration setting 'Alarms On' is configured to its factory default until your software is upgraded; and follow the instructions listed in the letter. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of the software upgrade. If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.

Device

IntelliVue MX40 Patient Monitor
  • Model / Serial
    SW Revisions: B.05.28, B.05.29, and B.05.32
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g || Product Number: 865352 || Exchange part: || 453564262491 || 453564262511 || 453564615311 || 453564615331 || 453564262571 || 453564262591 || Exchange part: || 453564262531 || 453564262551 || 453564262571 || 453564262591 || 453564615351 || 453564615371 || 453564467761 (Korea) || 453564467781 (Korea) || 453564451791 (Japan, Taiwan, Indonesia) || 453564451811 (Japan, Taiwan, Indonesia) || 453564467821 (Mexico) || 453564467841 (China) || 453564467861 (China) || Worldwide || SW Revisions: B.05.28, B.05.29, and B.05.32 || 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
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA