Events

Recall of IntelliVue Patient Monitoring

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems, Inc..

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
    67923
  • Event Risk Class
    Class 2
  • Event Number
    Z-1628-2014
  • Event Initiated Date
    2014-04-04
  • Event Date Posted
    2014-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126615
  • 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
    The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. such failure can result in overheating that in rare cases can cause the battery to ignite or explode.
  • Action
    Philips sent an Urgent: Medical Device Correction letter dated April 4, 2014 to all affected customers. The letter identified the affected product, problem, action to be taken and instructions for Use Addendum. Customers were instructed to review this information with all staff members who are involved in the operation and battery management of the IntelliVue patient Monitors and need to be aware of the contents of this communication. The addendum should be stored with the Monitor Instructions for Use. Please contact your local Philips representative or call us at 1-800-722-9377 with questions or concerns about this correction.

Device

IntelliVue Patient Monitoring
  • Model / Serial
    Patient Monitor Product numbers M3002A, M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8027A, M8001AU, M8002AU, M8003AU, and M8004AU with software releases up to and including G.0.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Including US Nationwide, Canada, Czech Republic, Denmark, Netherlands, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Kazakhstan, Norway, Poland, Romania, Russia, China, Slovakia, Sweden, and Turkey.
  • Product Description
    Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA