Events

Recall of SMARTMONITOR 2 WITH PCMCIA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDIGAS DIVISION OF PRAXAIR 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
    28519
  • Event Risk Class
    I
  • Event Initiated Date
    2009-05-08
  • 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
    There is a variation in the smartmonitor 2 manufacturing process that could allow the wire harness attached to the alarm to be pinched between the upper and lower case of the smartmonitor 2 units. if the wire harness is pinched such that the conductive wires are exposed they can short to the electrically conductive coating on the inside of the case. this can result in a situation where the alarm will not sound. however even if the audible alarm fails the unit will still trigger a visual alert (red lights will come on).

Device

SMARTMONITOR 2 WITH PCMCIA

Manufacturer

MEDIGAS DIVISION OF PRAXAIR CANADA INC.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Praxair, Inc.
  • Source
    HC