Events

Safety Alert for HeartStart MRx monitor/defibrillators, Model M3536A

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

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
    2012-05-03
  • Event Date Posted
    2012-05-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120503a.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
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: philips heartstart mrx monitor/defibrillators, model m3536a the medicines and healthcare products regulatory agency, united kingdom posted a field safety notice concerning all heartstart mrx monitor/defibrillators (model m3536a) with software versions r.01.00, r.02.00 or r.03.01. according to the manufacturer, philips healthcare, the affected devices may experience unexpected power cycling (system reboot) during device power on (startup). some devices have been observed to experience rebooting cycles for up to five minutes before the mrx stabilizes. there is a potential that therapy may be delayed. according to the local supplier, the affected devices had been distributed in hong kong and a software update will be provided to address the issue. if you are in possession of the affected product, please contact your supplier for necessary actions. posted 03 may 2012.

Device

HeartStart MRx monitor/defibrillators, Model M3536A
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillators, Model M3536A
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH