Events

Recall of Device Recall Philips IntellVue Info Center

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare 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
    64507
  • Event Risk Class
    Class 2
  • Event Number
    Z-1783-2014
  • Event Initiated Date
    2013-03-05
  • Event Date Posted
    2014-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116367
  • 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 alarm) - Product Code MHX
  • Reason
    If a customer creates customized trend scales in the trend review tile and the ix or primary server reboots for any reason, the ix(s) will enter a reboot loop. if one ix reboots, the issue will impact only those patients monitored on that device. if the primary server reboots, all patients across all ix devices will be impacted.
  • Action
    On 3/5/13, Philips sent each known affected customer an Urgent Medical Device Correction notification/Field Safety Notice to inform them that Philips has received a customer report that the PIC iX (release A.01.XX) central stations that are connected to a database server (DBS) may not be able to complete a restart/reboot resulting in the loss of central monitoring. In order to prevent this from occurring, customers were advised to not modify/customize the default trend scales for reviewing stored patient data in the retrospective review applications. Recall letter also states that a Philips Healthcare representative will contact customers with affected devices to arrange for the installation of updated PIIX iX software resolving this issue on affected units. Philips will conduct these updates for all affected devices at no charge.

Device

Device Recall Philips IntellVue Info Center
  • Model / Serial
    All iX versions with A.01 software
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • Product Description
    Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA