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
    72992
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-03
  • 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 identified a potential risk with the alaris system model 8015 manufactured between september 11 2012 and march 29 2013. the units manufactured during this time frame may display a system error code 133.6080 due to a failure with the super capacitor (c245) at power up on the alaris system logic boards (part numbers tc 10007253 and tc 100006939).

Device

ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Model / Serial
    Model Catalog: SERIAL #S 138XXXX >100 (Lot serial: 8015); Model Catalog: SERIAL #S 12706344 (Lot serial: 8015); Model Catalog: SERIAL #S 137XXXXX > 100 (Lot serial: 8015); Model Catalog: SERIAL #S 13691087 (Lot serial: 8015); Model Catalog: SERIAL #S 12992376 (Lot serial: 8015)
  • Product Description
    Alaris System - Alaris Server Mobile
  • Manufacturer
    CAREFUSION 303 INC.

Manufacturer

CAREFUSION 303 INC.