Events

Recall of AQUILION 64 SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TOSHIBA CANADA MEDICAL SYSTEMS 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
    153729
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-27
  • 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
    In the aquilion system the following software issues have been noted (1)the confirmation may not be displayed properly during scanoscopy (2)if the pgp hard split option is used and the scano skip button is pressed the second scanoscopy may not be completed (3)the use of pgp hard split may result in an error in image display processing (4)if more than 10 characters is entered in the image comment the system software will terminate abnormally. (5) under certain circumstances if the helical skip button is clicked during one of the scanning the next helical scan may stop before it is completed.

Device

AQUILION 64 SYSTEM
  • Model / Serial
    Model Catalog: TSX-101A/H (Lot serial: S/N: HCB1083821); Model Catalog: TSX-101A/H (Lot serial: S/N: HCB10X3839); Model Catalog: TSX-101A/H (Lot serial: S/N: HCB1083820); Model Catalog: TSX-101A/H (Lot serial: S/N: HCB1023750)
  • Product Description
    AQUILION 64
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

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