Events

Recall of POWERHEART AED G3 AUTOMATIC

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

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
    18898
  • Event Risk Class
    II
  • Event Initiated Date
    2011-09-08
  • 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
    Cardiac science was aware that certain aeds have resistors which may fail and the failure would not be detected by the aeds' periodic self-tests.

Device

POWERHEART AED G3 AUTOMATIC
  • Model / Serial
    Model Catalog: POWERHEART 9300A (Lot serial: >100 numbers contact mfg); Model Catalog: POWERHEART 9300E (Lot serial: >1000 numbers contact mfg); Model Catalog: CARDIOVIVE 92532 (Lot serial: Serial # 4022088); Model Catalog: CARDIOVIVE 92532 (Lot serial: Serial # 4035451); Model Catalog: CARDIOVIVE 92532 (Lot serial: Serial # 4037302); Model Catalog: CARDIOVIVE 92532 (Lot serial: Serial # 92532-0000794); Model Catalog: CARDIOVIVE 92532 (Lot serial: Serial # 4018084); Model Catalog: CARDIOVIVE 92530 (Lot serial: Serial # 92530-0000413); Model Catalog: POWERHEART 9390A (Lot serial: >100 numbers contact mfg); Model Catalog: POWERHEART 9390E (Lot serial: >100 numbers contact mfg); Model Catalog: FIRSTSAVE 9300C (Lot serial: Serial # 335430); Model Catalog: POWERHEART 9300P (Lot serial: >10 numbers contact mfg)
  • Product Description
    POWERHEART AED G3 AUTOMATIC
  • Manufacturer
    SURGO SURGICAL SUPPLY

Manufacturer

SURGO SURGICAL SUPPLY
  • Manufacturer Address
    KESWICK
  • Source
    HC