Events

Safety Alert for HeartStart FR2+ M3860A, M3861A, M3840A and M3841A

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Electronics Hong Kong Ltd..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2010-06-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20100603.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Press release
  • Reason
    Recall of automated external defibrillators the department of health (dh) today (june 1) drew public attention to a voluntary recall by the philips electronics hong kong ltd. of four models of automated external defibrillators (aeds) which may have voltage detector problems. the affected models are heartstart fr2+ m3860a, m3861a, m3840a and m3841a. investigation conducted by the manufacturer revealed that the units may contain a component called a voltage detector from lots that have a higher than expected rate of failure, which can cause the aed battery to drain more rapidly than normal or to render the aed unusable. according to philips electronics hong kong ltd, a total of 46 units of the affected models of aeds have been sold to clinics, medical professional organisations and commercial organisations and the company has alerted its purchasers. those who possess the affected models should contact the company by calling its hotline 2876 7578 for advice. dh has not received any report of adverse incidents arising from this issue and will work closely with the company to monitor the recall. 1 jun 2010.

Device

HeartStart FR2+ M3860A, M3861A, M3840A and M3841A

Manufacturer

Philips Electronics Hong Kong Ltd.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH