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 CAREFUSION 303 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
    63083
  • Event Risk Class
    III
  • Event Initiated Date
    2015-03-19
  • 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
    Carefusion has received service reports from customers experiencing a system error(code 110.6021) during power on due to misaligned keypad dome causing an error during the power on self test (post).

Device

ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Model / Serial
    Model Catalog: 8015 (Lot serial: multiple lots. contact mfg)
  • Product Description
    CareFusion Alaris PC Unit model 8015
  • Manufacturer
    CAREFUSION 303 INC.

Manufacturer

CAREFUSION 303 INC.