Events

Recall of Device Recall Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX

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
    63709
  • Event Risk Class
    Class 2
  • Event Number
    Z-0495-2013
  • Event Initiated Date
    2012-11-09
  • Event Date Posted
    2012-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114593
  • 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
    Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.
  • Action
    Philips sent an URGENT - Medical Device Correction letter dated November 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips is conducting a voluntary correction to replace the audio cable on affected devices. Customer were instructed to follow the "Action to be taken by CustomerUser" section of the instructions. Customers with wquestions were instructed to contact their Phililps representataive or contact the Customer Care Solutions Center at (800) 722-9377. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips IntelliVue Information Center/Client and Philips IntelliVue Information Ce...
  • Model / Serial
    PIIC 865435 M3140 Information Center Low Acuity 865436 M3150 Information Center Local DB 865417 M3145 Information Center Small NW DB 865418 M3155 Information Center NW DB 865415 M3151 Information Center Client 865421  M3170 Patient Link 865416  M3177 Trend Display 865422  M3140 Upgrade 865423  M3150 Upgrade 865426  M3145 Upgrade 865427  M3155 Upgrade 865424  M3151 Upgrade 865266 - M3140 Information Center Low Acuity 865267  M3150 Information Center Local DB 865269  M3145 Information Center Small NW DB 865268  M3155 Information Center NW DB 865270  M3151 Information Center Client 865274  M3170 Patient Link 865271  M3177 Trend Display 865277  M3140 Upgrade 865278  M3150 Upgrade 865281  M3145 Upgrade 865282  M3155 Upgrade 865279  M3151 Upgrade  PIIC iX 866023  IntelliVue Info Center iX 866117  PIIC Classic Upgrade 866027  PIIC iX HW Upgrade
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Product Description
    Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX || The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
  • 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