Events

Recall of SMARTSTIM TDCS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NURALEVE INC. ALSO OPERATING AS NORDOCS TECHNOLOGIES.

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
    134159
  • Event Risk Class
    III
  • Event Initiated Date
    2014-08-20
  • 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
    A single computer connected to more than one smartstim model 200 device. in some instances as in the case with computers with slower/less powerful cpus this presented a problem. when more than a single device was connected to a single pc what could happen is that the connection would drop causing the tdcs stimulation to stop. there is a mild risk of seeing a flash of light because of the abrupt interruption of the stimulation otherwise no injuries could occur in such a scenario.

Device

SMARTSTIM TDCS

Manufacturer

NURALEVE INC. ALSO OPERATING AS NORDOCS TECHNOLOGIES
  • Manufacturer Address
    OTTAWA
  • Source
    HC