Events

Field Safety Notices about AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Access CardioSystems Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2004(10)
  • Date
    2004-11-15
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/accessaed-pad-accessaed-and-accessals-automated-external-defibrillator-devices&id=889af825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    Recall of specified serial numbers of accessaed pad (model numbers 9100-0010-0 and 9100-0015-0), accessaed (model numbers 9100-0100-0, 9100-0100-1, 9100-0150-0, and 9100-0150-1), and accessals (model numbers 9100-0100-2 and 9100-0150-2) automated external defibrillator devices and discontinued support by the manufacturer of all other devices that are in use.
  • Action
    Ensure that relevant all staff are advised of this Safety Notice. Ensure that all specified serial numbers listed below are immediately removed from use: AccessAED PAD, AccessAED, AccessALS, serial numbers 075180 – 084760 Replace all other AEDs, not specified in the scope of the recall, as soon as possible

Device

AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices

Manufacturer

Access CardioSystems Inc.
  • Source
    HPRA