Events

Recall of Device Recall Central Station Monitor

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

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
    25430
  • Event Risk Class
    Class 2
  • Event Number
    Z-0597-03
  • Event Initiated Date
    2003-01-02
  • Event Date Posted
    2003-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25821
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Central station monitoring information centers may experience sreeen freeze, i.E. loss of display, keyboard or mouse lock up.
  • Action
    Philips Medical Systems notified users by Certified Mail on/about 2/19/03 that the firm was initiating a device field correction (recall) to conduct an upgrade to units witha HP VL400 or VL420 computer which is cconfigured for dual display by replacing the video and network communication card. Previous to this notification, Philips sent letters on 1/2/03 addressed to Biomedical Engineering Manager to advise users to reboot the system in the event of a system freeze.

Device

Device Recall Central Station Monitor

Manufacturer

Philips Medical Systems, Inc. Cardiac & Monitoring Systems
  • Manufacturer Address
    Philips Medical Systems, Inc. Cardiac & Monitoring Systems, 3000 Minuteman Road, Andover MA 01810
  • Source
    USFDA