Events

Recall of Device Recall Philips Intellivue Central Station Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical 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
    38400
  • Event Risk Class
    Class 2
  • Event Number
    Z-1182-2007
  • Event Initiated Date
    2007-07-16
  • Event Date Posted
    2007-09-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53538
  • 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
    Central Station Software - Product Code MHX
  • Reason
    Incorrect patient assignment: the information center will in most cases be associated with the "incorrect" patient. this occurs on both standalone and networked systems running fixed mode monitoring. (this does not occur on systems that run flex mode monitoring).
  • Action
    Philips Medical Systems issued a letter notification dated July 2007 " Urgent Device Correction". Customers with networked information centers will be corrected through a database server. Stand-Alone units will have a software correction. Software version J.00.25 will correct the problem. Users are advised not to use th 12 Lead Analysis and Export Option in fixed or flex mode monitoring unitl the software correction is made.

Device

Device Recall Philips Intellivue Central Station Software
  • Model / Serial
    Software versions: J.00.23 and J.00.24 (You can determine the application software release as follows: 1-Enter Service Mode through "All Controls" , "Service" 2-Under the "Other Services " menu item, click "Software Versions" 3-"Application" lists the application software version.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK
  • Product Description
    Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station || Models: M3145, M3150, M3154, M3155, M3169
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA