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
    46187
  • Event Risk Class
    II
  • Event Initiated Date
    2012-07-11
  • 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
    A potential risk has been identified that is associated with the power supply board used with the alaris pc unit model 8015 manufactured after january 2011. a component (u21) on this power supply board is causing an error code (120.4630) "system error" or "missing battery error" at start up. when the 120.4630 "system error" code or "missing battery error" error code is observed this could cause a potential delay of therapy at start up or if observed while infusing the inability to make programming changes to current infusions which may result in serious injury and /or death. during infusion the buttons on the channel operate as expected. this error code has not been confirmed to occur during infusion.

Device

ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Model / Serial
    Model Catalog: 8015 (Lot serial: Contact manufacturer.); Model Catalog: 8015 (Lot serial: >10 serial numbers.)
  • Product Description
    Alaris PC Unit model 8015
  • Manufacturer
    CAREFUSION 303 INC.

Manufacturer

CAREFUSION 303 INC.