Events

Recall of HEARTSTART 4000 DEFIBRILLATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HEALTH INDUSTRY CONSULTANTS.

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
    16316
  • Event Risk Class
    I
  • Event Initiated Date
    2001-02-09
  • 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
    Some units may shut down or fail to power on due to a failure of a component located on a circuit board with no early indication or warning that the fault has or will occur before power on or during operation.^.

Device

HEARTSTART 4000 DEFIBRILLATOR
  • Model / Serial
    Model Catalog: M5500B (Lot serial: US00100933 US00101022); Model Catalog: M5500B (Lot serial: US00100670 US00100669); Model Catalog: M5500B (Lot serial: US00100665 US00100671); Model Catalog: M5500B (Lot serial: US00100353 US00100352); Model Catalog: M5500B (Lot serial: US00100546.); Model Catalog: M5500B (Lot serial: US00100672 US00100371); Model Catalog: M5500B (Lot serial: US00100238 US00100240); Model Catalog: M5500B (Lot serial: US00100241 US00100246); Model Catalog: M5500B (Lot serial: US00100250 US00100252); Model Catalog: M5500B (Lot serial: US00100508 US00100509); Model Catalog: M5500B (Lot serial: US00100992 US00100558)
  • Product Description
    HEARTSTART 4000 MODEL M5500B DEFIBRILL
  • Manufacturer
    HEALTH INDUSTRY CONSULTANTS

Manufacturer

HEALTH INDUSTRY CONSULTANTS
  • Manufacturer Address
    ETOBICOKE
  • Source
    HC