Events

Recall of APLIO 300 - MAIN UNIT

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
    105076
  • Event Risk Class
    II
  • Event Initiated Date
    2013-02-15
  • 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
    Proper startup of toshiba diagnostic ultrasound systems for models tus-a500/tus-a400/tus-a300. if the operating procedure is not followed properly when starting up the system the system may not properly start up. the system cannot start normally within 15 seconds from connecting the power plug due to its power supply unit limitation the procedure is described in the operation manual. the power supply unit will be changed on all affected units.

Device

APLIO 300 - MAIN UNIT
  • Model / Serial
    Model Catalog: TUS-A300 (Lot serial: >100 NUMBERSCONTACT MFG); Model Catalog: TUS-A500 (Lot serial: >100 NUMBERSCONTACT MFG); Model Catalog: TUS-A400 (Lot serial: >100 NUMBERSCONTACT MFG)
  • Product Description
    APLIO 300 - MAIN UNIT
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

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