Events

Recall of Device Recall Philips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

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
    76079
  • Event Risk Class
    Class 2
  • Event Number
    Z-1106-2017
  • Event Initiated Date
    2016-12-27
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152105
  • 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
    Medical device data system - Product Code OUG
  • Reason
    May experience a loss of centralized monitoring.
  • Action
    Philips sent an Field Safety Notice on December 27, 2016, to customers via certified mail. The notice explains the issue and informs the customers that no actions are required. The product may be used until the replacement cable is made available. If you need any further information or support concerning this issue, please call your local Philips Representative at (800) 722-9377.

Device

Device Recall Philips
  • Model / Serial
    InfiniBand cables shipped between June 22, 2016 and October 6, 2016 in use with the Cisco 3850 switch.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : AK CA CO FL GA KY NC NE NH NJ NY OH PA SC TN TX VA WA and WV., and to the countries of : Canada, Germany, Japan, New Zealand, Poland and United Kingdom
  • Product Description
    Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA