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
    42074
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-03
  • 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
    In systems with the ecg modulation function which permits the tube current to be adjusted in synchronization with the ecg waveform it has been found that in ct examinations using this function x-ray output may not be varied as specified. as a result an error may occur and scanning may be interrupted.

Device

AQUILION 64 SYSTEM
  • Model / Serial
    Model Catalog: TSX-101A/HX (Lot serial: S/N: HDA0632105); Model Catalog: TSX-101A/E (Lot serial: S/N: ECA0552037); Model Catalog: TSX-101A/H (Lot serial: S/N: HDA0632105); Model Catalog: TSX-101A/E (Lot serial: S/N: HDA0632105); Model Catalog: TSX-101A/HX (Lot serial: S/N: HCA07Y3000); Model Catalog: TSX-101A/EX (Lot serial: S/N: HCA07Y3000); Model Catalog: TSX-101A/H (Lot serial: S/N: HCA07Y3000); Model Catalog: TSX-101A/E (Lot serial: S/N: HCA07Y3000); Model Catalog: TSX-101A/HX (Lot serial: S/N: HCA07X2919); Model Catalog: TSX-101A/EX (Lot serial: S/N: HCA07X2919); Model Catalog: TSX-101A/H (Lot serial: S/N: HCA07X2919); Model Catalog: TSX-101A/E (Lot serial: S/N: HCA07X2919); Model Catalog: TSX-101A/HX (Lot serial: S/N: HCA0782875); Model Catalog: TSX-101A/EX (Lot serial: S/N: HCA0782875); Model Catalog: TSX-101A/H (Lot serial: S/N: HCA0782875); Model Catalog: TSX-101A/E (Lot serial: S/N: HCA0782875); Model Catalog: TSX-101A/HX (Lot serial: S/N: HCA06Z2467); Model Catalog: TSX-101A/EX (Lot serial: S/N: H
  • Product Description
    AQUILION 64 SYSTEM
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

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