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-0596-03
  • 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=25820
  • 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
  • Model / Serial
    Serial 4225A00106 4225A00107 4225A00108 4225A00111 4225A00112 4225A00113 4225A00114 4225A00116 4225A00117 4225A00118 4225A00119 4225A00127 4225A00145 4225A00149 4225A00150 4225A00151 4225A00152 4225A00164 4225A00165 4225A00166 4225A00167 4225A00169 4225A00188 4225A00189 4213A13698 4213A13700 4225A00122 4225A00136 4225A00138 4225A00137 4225A00139 4225A00140 4225A00142 4225A00143 4225A00144 4225A00101 4225A00102 4225A00103 4225A00104
  • Product Classification
    Cardiovascular Devices
  • Distribution
    Nationwide Canada, Europe, Asia, Latin America
  • Product Description
    Intellivue Information Center || Model: M3150B#C01
  • Manufacturer
    Philips Medical Systems, Inc. Cardiac & Monitoring Systems

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