Events

Recall of SMART MONITORS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESPIRONICS 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
    77642
  • Event Risk Class
    II
  • Event Initiated Date
    2004-07-07
  • 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
    Breaking of the wire due to excessive tin being added to the end of the lead wire which permitted the plastic cover of some wires to be tinned. excessive tinning caused affected wires to be more fragile.

Device

SMART MONITORS
  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    RESPIRONICS MODEL 915 BATTERY PACK
  • Manufacturer
    RESPIRONICS INC.

Manufacturer

RESPIRONICS INC.
  • Manufacturer Address
    MURRYSVILLE
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC