Events

Recall of ARKON ANESTHESIA SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SPACELABS HEALTHCARE (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
    93766
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-27
  • 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
    The system status computer may incorrectly determine that a communication error has occurred. if this situation occurs a buzzer will activate and a yellow triangle will be displayed on the system status computer screen that alerts the user of this error. no other status information will be shown on the system status computer display and pipeline supply alarms will be disabled. this error is caused by a 25 day software clock that is not being reset properly. all other functions and alarms continue to operate normally. there have been no injuries reported as a result of this issue.

Device

ARKON ANESTHESIA SYSTEM
  • Model / Serial
    Model Catalog: ARKON (Lot serial: ARKN-000005); Model Catalog: ARKON (Lot serial: ARKN-000015)
  • Product Description
    Arkon Anesthesia System
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

SPACELABS HEALTHCARE (CANADA) INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    HC