Events

Recall of AMI PLUS INFANT CENTRAL APNEA/HEART RATE MONITOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIEBEL-FLARSHEIM 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
    78207
  • Event Risk Class
    II
  • Event Initiated Date
    2002-04-18
  • 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
    Infant monitor may shut down and fail to alarm audibly when exposed to high levels of static electricty(esd) in home environments.

Device

AMI PLUS INFANT CENTRAL APNEA/HEART RATE MONITOR
  • Model / Serial
    Model Catalog: L-9700 (Lot serial: DEV LIC 19176 29267); Model Catalog: L-9700A (Lot serial: DEV LIC 19176 29267); Model Catalog: L-9700A (Lot serial: MODEL 9700 0700A 9700B); Model Catalog: L-9700 (Lot serial: MODEL 9700 0700A 9700B)
  • Product Description
    AMI PLUS 9700B APNEA MONITOR
  • Manufacturer
    LIEBEL-FLARSHEIM CANADA INC.

Manufacturer

LIEBEL-FLARSHEIM CANADA INC.
  • Manufacturer Address
    POINTE-CLAIRE
  • Source
    HC