Events

Recall of AQUILION ONE SYSTEM - SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANON MEDICAL SYSTEMS CANADA LIMITED.

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
    135540
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-21
  • 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
    In the aquilion one systems with cfa option (optional ct cardiac function analysis- herinafter referred to as cfa) it has been found that correct analysis results may not be displayed.

Device

AQUILION ONE SYSTEM - SOFTWARE
  • Model / Serial
    Model Catalog: CSCF-003A (Lot serial: S/N: 1BC0872022); Model Catalog: CSCF-003A (Lot serial: S/N: 1BA1022087); Model Catalog: CSCF-003A (Lot serial: S/N: 1BA08Z2048); Model Catalog: CSCF-003A (Lot serial: S/N: 1BC0882035); Model Catalog: CSCF-003A (Lot serial: S/N:1BA0822013); Model Catalog: CSCF-003A (Lot serial: S/N:1BC0882036); Model Catalog: CSCF-003A (Lot serial: S/N:1BC08X2041); Model Catalog: CSCF-003A (Lot serial: S/N:1BC09X2075); Model Catalog: CSCF-003A (Lot serial: S/N: 1BB0852020)
  • Product Description
    AQUILION ONE SYSTEM - SOFTWARE
  • Manufacturer
    CANON MEDICAL SYSTEMS CANADA LIMITED

Manufacturer

CANON MEDICAL SYSTEMS CANADA LIMITED
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    HC