Events

Recall of LIFEPAK CR PLUS - LITHIUM CHARGE-PAK

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
    92536
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-26
  • 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
    To notify customers who own lifepak cr plus and/or lifepak express aeds potentially affected by an issue that may cause internal battery depletion earlier than expected.

Device

LIFEPAK CR PLUS - LITHIUM CHARGE-PAK
  • Model / Serial
    Model Catalog: 3200731-XXX (Lot serial: >1000 numbers contact mfg); Model Catalog: 3202359-XXX (Lot serial: >1000 numbers contact mfg); Model Catalog: 3200731-XXX (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: 3202177-XXX (Lot serial: >10 numbers contact mfg)
  • Product Description
    Lifepak CR Plus Automated External Defibrillator (Automatic AED)
  • Manufacturer
    IRIDIA MEDICAL

Manufacturer

IRIDIA MEDICAL