Events

Recall of POWERHEART - AED G3 (BIPHASIC)

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

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
    65175
  • Event Risk Class
    II
  • Event Initiated Date
    2009-11-20
  • 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
    Review of test records indicated that the seven impacted powerhart g3 aeds manufactured by cardiac science corporation (csc) may not have received adequate testing prior to being shipped from the factory.

Device

POWERHEART - AED G3 (BIPHASIC)
  • Model / Serial
    Model Catalog: 9300E-501 (Lot serial: Serial # 4153683); Model Catalog: 9300E-501 (Lot serial: Serial # 4153329); Model Catalog: 9300E-501 (Lot serial: Serial # 4218441); Model Catalog: 9300A-501PPC (Lot serial: Serial # 4230260ppc); Model Catalog: 9300P-601 (Lot serial: Serial # 4226121); Model Catalog: 9390E-501 (Lot serial: Serial # 4237595); Model Catalog: 9390A-501 (Lot serial: Serial # 4183220)
  • Product Description
    Powerheart - AED G3 (Biphasic)
  • Manufacturer
    CARDIAC SCIENCE CORPORATION

Manufacturer

CARDIAC SCIENCE CORPORATION