Events

Safety Alert for HeartStart MRx/MRxE M3535A and HeartStart XL M4735A

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
    2009-04-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20090425.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 (april 24) alerted the public of a voluntary recall by the manufacturer of two models of automated external defibrillator (aed) which have switch problem. the affected models are heartstart mrx/mrxe m3535a and heartstart xl m4735a. investigation conducted by the manufacturer, philips healthcare, revealed that failures are more likely to occur in devices that have been exposed to high heat and humidity, which contribute to accelerated internal degradation of switch components over time. about 270 aed of the two models have been introduced to hong kong, mostly to public and private hospitals. philips healthcare has alerted its purchasers. people should not use the aed of the affected models and contact the company by calling its hotline 2876 7578 for advice. dh has not received any report of adverse events arising from this issue and will closely monitor the recall. ends.

Device

HeartStart MRx/MRxE M3535A and HeartStart XL M4735A
  • Model / Serial
  • Product Description
    Press release: Recall of Automated External Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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