Events

Recall of HIGH DEFINITION DRSHD 1080P

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MED X CHANGE 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
    152903
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-05
  • 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
    This voluntary recall has been initiated on drshd 1080p units due to a manufacturing defect in an internal cable. the use of this product may cause this cable to heat up which will melt the plastic and consequently produces smoke.

Device

HIGH DEFINITION DRSHD 1080P
  • Model / Serial
    Model Catalog: DRSHD 1080P (Lot serial: S/N:DRSHD-0613-006C); Model Catalog: DRSHD 1080P (Lot serial: S/N:DRSHD-0613-004C); Model Catalog: DRSHD 1080P (Lot serial: S/N:DRSHD-0613-003C); Model Catalog: DRSHD 1080P (Lot serial: S/N:DRSHD-0813-041C); Model Catalog: DRSHD 1080P (Lot serial: S/N:DRSHD-0313-003C); Model Catalog: DRSHD 1080P (Lot serial: S/N:DRSHD-0813-030C); Model Catalog: DRSHD 1080P (Lot serial: S/N:DRSHD-0813-053C); Model Catalog: DRSHD 1080P (Lot serial: S/N:DRSHD-0813-049C)
  • Product Description
    HIGH DEFINITION DRSHD 1080P
  • Manufacturer
    MED X CHANGE INC.

Manufacturer

MED X CHANGE INC.
  • Manufacturer Address
    BRADENTON
  • Manufacturer Parent Company (2017)
    Med X Change Inc.
  • Source
    HC