Events

Recall of X-RAY HIGH-VOLTAGE GENERATOR

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
    107210
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-02
  • 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
    It has been found that when radiographic conditions with the small focus are set and the radiography ready switch is held down the large focus is also heated after a few seconds or more. as a result a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired when the aec (automatic exposure control) function is not used.

Device

X-RAY HIGH-VOLTAGE GENERATOR
  • Model / Serial
    Model Catalog: KXO-80XD (Lot serial: S/N: 99A0542035X); Model Catalog: KXO-80XM/J1 (Lot serial: S/N: J1H0933456); Model Catalog: KXO-80XM (Lot serial: S/N: J1H0933456); Model Catalog: KXO-80XM (Lot serial: S/N: F3532527); Model Catalog: KXO-80XM (Lot serial: S/N: J1H0713302); Model Catalog: KXO-80XM/J1 (Lot serial: S/N: J1G0653183); Model Catalog: KXO-80XM (Lot serial: S/N: J1G0653183); Model Catalog: KXO-80XM/J1 (Lot serial: S/N: F3532527); Model Catalog: KXO-80XD (Lot serial: S/N: 99C1192362); Model Catalog: KXO-80XM/J1 (Lot serial: S/N: J1H0713302)
  • Product Description
    X-RAY HIGH-VOLTAGE GENERATOR
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

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