Events

Recall of Device Recall IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (P

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
    68349
  • Event Risk Class
    Class 2
  • Event Number
    Z-1746-2014
  • Event Initiated Date
    2014-05-22
  • Event Date Posted
    2014-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127391
  • 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
    Intellivue mx40 (part numbers 865350, 865352) with software revisions b.00 or b.01 may not resume alarming when the alarms are paused and the pause timer ends.
  • Action
    On May 22, 2014, each affected customer was sent an Urgent Medical Device Correction notification/Field Safety Notice. The letter explains the problem, explains the action to be taken by the consumer, and the action planned by Philips. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a free of charge software upgrade. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: The following two items must be configured when using MX40 with the IntelliVue Information Center iX: 1. Utilize the default state of Pause Alarms at Yellow only, which disables the ability to Pause/Suspend all Red level alarms Utilize the default state of Remote Suspend Alarms as Off, which disables the use of the Pause Alarms feature at the MX40 device

Device

Device Recall IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Inform...
  • Model / Serial
    Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, Turkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates, Hong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon
  • Product Description
    IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
  • 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