Events

Recall of ISOLETTE INFANT INCUBATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL INFANT CARE 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
    26756
  • Event Risk Class
    III
  • Event Initiated Date
    2000-07-07
  • 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
    Addenum to may 1998 recall. failures documented with air flow probe temperature and hunidity variations excessive heat generation resulting in smoke emission plastic deformation. alarm failure.

Device

ISOLETTE INFANT INCUBATOR

Manufacturer

DRAEGER MEDICAL INFANT CARE INC.
  • Manufacturer Address
    TELFORD
  • Source
    HC