Events

Recall of ULTIMAX-I

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANON MEDICAL SYSTEMS CANADA 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
    27001
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-16
  • 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 in the angiography examination of the lower extremity the protection function of the x-ray high voltage generator was activated during continuous x-ray image acquisition and the x-ray irradiation sequence stopped halfway.

Device

ULTIMAX-I
  • Model / Serial
    Model Catalog: DREX-UI80_/K2 (Lot serial: >10 numbers contact mfg); Model Catalog: DREX-UI80_/K1 (Lot serial: >10 numbers contact mfg); Model Catalog: DREX-U180_/K2 (Lot serial: >10 numbers contact mfg); Model Catalog: DREX-U180_/K1 (Lot serial: >10 numbers contact mfg); Model Catalog: DREX-ZX80_/K4 (Lot serial: >10 numbers contact mfg); Model Catalog: DREX-ZX80_/K3 (Lot serial: >10 numbers contact mfg); Model Catalog: DREX-ZX80_/K2 (Lot serial: >10 numbers contact mfg); Model Catalog: DREX-ZX80_/K1 (Lot serial: >10 numbers contact mfg)
  • Product Description
    ULTIMAX-I;REMOTE CONTRL R/F SYSTEM ZEXIRA - MAIN UNIT
  • Manufacturer
    CANON MEDICAL SYSTEMS CANADA LIMITED

Manufacturer

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