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
    27777
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-30
  • 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
    By the inappropriate processing of the software for the image-processing device(hdr-08a) one-shot images are saved as black images in the hard disk and they are displayed as black images on the system monitor even though these images are displayed normally on the live monitor.

Device

ULTIMAX-I
  • Model / Serial
    Model Catalog: DREX-UI80_/K2 (Lot serial: >10 numbers contact mfg); Model Catalog: DREX-U180_/K1 (Lot serial: >10 numbers contact mfg); Model Catalog: HDR-08A (Lot serial: >10 numbers contact mfg); Model Catalog: DREX-ZX80_/K4 (Lot serial: >10 numbers contact mfg)
  • Product Description
    ULTIMAX-I
  • Manufacturer
    CANON MEDICAL SYSTEMS CANADA LIMITED

Manufacturer

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