Events

Recall of APLIO XG ULTRASOUND SYSTEM - MAIN

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
    28589
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-01
  • 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
    When scanning with imaging preset of fetal heart pediatric heart adult heart or coronary in certain software versions of aplio xg and xario xg the patient-contact surface of transducer pst-65at may become abnormally hot when a different imaging preset is selected during the same study. this is a software issue.

Device

APLIO XG ULTRASOUND SYSTEM - MAIN
  • Model / Serial
    100 NUMBERS CONTACT MFG"); Model Catalog: SSA-680A (Lot serial: ">100 NUMBERS CONTACT MFG")" v-b-tooltip> Model Catalog: SSA-790A (Lot serial: ">100 NUMBERS CONTACT MFG"); Model Catalog: SSA-680A (Lot serial: ">100 NUMBERS CONTACT MFG")
  • Product Description
    APLIO XG ULTRASOUND SYSTEM - MAIN
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

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