Events

Recall of ULTIMAX-I

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
    27531
  • Event Risk Class
    III
  • Event Initiated Date
    2012-10-17
  • 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 ultimax-i systems with certain combinations when beam limiting device operation is switched to the remote control console while beam limiting device is rotated it may result in the beam limiting device aperture opening and possibly resulting in setting of an exposure field larger than the image receptor size.

Device

ULTIMAX-I
  • Model / Serial
    Model Catalog: DREX-UI80_/K1 (Lot serial: K1A1142005); Model Catalog: DREX-UI80_/K1 (Lot serial: K1C2333010); Model Catalog: DREX-UI80_/K1 (Lot serial: K1C1222011); Model Catalog: DREX-UI80_/K1 (Lot serial: K1C1252012); Model Catalog: DREX-UI80_/K1 (Lot serial: K1C1252013); Model Catalog: DREX-UI80_/K1 (Lot serial: K1C1222009)
  • Product Description
    ULTIMAX-I
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

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