Events

Recall of RADPRO MOBILE 3 40KW

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CANON CANADA INC..

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
    19001
  • Event Risk Class
    II
  • Event Initiated Date
    2015-09-29
  • 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
    Electrostatic energy may be stored in systems that can cause a short-circuit which in tun can generate an electomagnetic pulse which might disturb the electronics of the digital motion control board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or patient.

Device

RADPRO MOBILE 3 40KW
  • Model / Serial
    Model Catalog: MOBILE 3 40KW 50G/C (Lot serial: S/N between G29393 and G62480)
  • Product Description
    RadPRO 40kW - Digital Mobile X-Ray System
  • Manufacturer
    CANON CANADA INC.

Manufacturer

CANON CANADA INC.
  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    HC