Events

Recall of ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA 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
    27117
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-01
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    If the pc unit is running on battery power a low battery alarm and/or very low battery alarm should activate when 30 minutes and 5 minutes of estimated battery runtime remains. in some cases these low battery alarms will not be generated before the pc unit displays a battery discharged alarm and all infusion channels are stopped.

Device

ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Model / Serial
    Model Catalog: 8000 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 8015 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    ALARIS SYSTEM PC UNIT MODELS 8000 AND 8015
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.