Events

Recall of LIFEPAK CR PLUS AED (SEMIAUTOMATIC OPERATION)

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

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
    17138
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-04
  • 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
    Physio-control has become aware of an issue whereby the lifepak cr plus aed or lifepak expressaed may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. physio-control has determined that there are presently 25178 devices in the field of which approximately 9600 may have this faulty component. a defibrillator in this condition is not delivered and a patient is not resuscitated. all reports received from customers have been noted during initial set up and testing of the device.

Device

LIFEPAK CR PLUS AED (SEMIAUTOMATIC OPERATION)
  • Model / Serial
    Model Catalog: 99403-000209 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000280 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000278 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3202359-092 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3202359-019 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3200731-XXX (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 3202359-XXX (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99403-000156 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99427-000133 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99427-000129 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80427-000156 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80427-000155 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000279 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 80403-000281 (Lot serial: > 1000 NUMBERS CONTACT MFG); Model Catalog: 99403-000210 (Lot serial: > 1000
  • Product Description
    LIFEPAK CR Plus (Semi-Automatic);LifepaK CR Express (Semi-Automatic Operation);LIFEPAK CR Express (Semi-Automatic Operation);LIFEPAK CR Plus (Fully Automatic)
  • Manufacturer
    IRIDIA MEDICAL

Manufacturer

IRIDIA MEDICAL