Events

Recall of POWERHEART G3 PLUS AUTOMATIC

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEVITT-SAFETY LIMITED.

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
    54123
  • Event Risk Class
    I
  • Event Initiated Date
    2014-10-30
  • 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
    The affected aeds contain a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. if the component were to fail during a rescue attempt the saed may not deliver defibrillation therapy.

Device

POWERHEART G3 PLUS AUTOMATIC
  • Model / Serial
    Model Catalog: 9390A-XXX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 9300A-XXX (Lot serial: 4384671SP); Model Catalog: 9300A-XXX (Lot serial: 4384674SP); Model Catalog: 9300A-XXX (Lot serial: 4384711SP); Model Catalog: 9300A-XXX (Lot serial: 4379885); Model Catalog: 9300A-XXX (Lot serial: 4374165); Model Catalog: 9300A-XXX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 9300A-XXX (Lot serial: 4384724SP); Model Catalog: 9300A-XXX (Lot serial: 4384732SP); Model Catalog: 9300A-XXX (Lot serial: 4384725SP); Model Catalog: 9390E-XXX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 9390E-XXX (Lot serial: 4383669SP); Model Catalog: 9390E-XXX (Lot serial: 4386329SP); Model Catalog: 9390E-XXX (Lot serial: 4386317SP); Model Catalog: 9300E (Lot serial: Contact Manufacturer.); Model Catalog: 9300E (Lot serial: >10 Serial numbers.); Model Catalog: 9300E (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    POWERHEART G3 PLUS AUTOMATIC
  • Manufacturer
    LEVITT-SAFETY LIMITED

Manufacturer

LEVITT-SAFETY LIMITED