Events

Recall of AUTOPULSE RESUSCITATION SYSTEM - BATTERY AND CHARGER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZOLL CIRCULATION 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
    39781
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-20
  • 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
    Complaints associated with an unexpected stop in autopulse compressions are most commonly caused when users do not properly perform required daily readiness and battery maintenance tasks. these battery maintenance tasks need to be made absolutely clear and followed in order for the product to perform as intended.

Device

AUTOPULSE RESUSCITATION SYSTEM - BATTERY AND CHARGER
  • Model / Serial
    Model Catalog: 8700-0753-XX/12441-XX (Lot serial: Model 100); Model Catalog: 8700-0752-XX/12508-XX (Lot serial: Model 100); Model Catalog: 8700-0703-XX/10630-XXX (Lot serial: Model 100); Model Catalog: 8700-0700-XX/11486-XXX (Lot serial: Model 100); Model Catalog: 8700-0740-XX/11807-XXX (Lot serial: Model 100); Model Catalog: 8700-0730-XX*/11574-XXX* (Lot serial: Model 100); Model Catalog: 8700-0702-XX/10627-XXX (Lot serial: Model 100); Model Catalog: 8700-0704-XX/10504-XXX (Lot serial: Model 100); Model Catalog: 8700-0706-XX/11130-XXX (Lot serial: Model 100)
  • Product Description
    AutoPulse Resuscitation System Model 100
  • Manufacturer
    ZOLL CIRCULATION INC.

Manufacturer

ZOLL CIRCULATION INC.