Events

Recall of Philips HeartStart MRx Monitor/Defibrillator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

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
    RC-2014-RN-01268-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01268-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The handle can separate from the mrx housing due to breakage of mounts on the rear case. separation of the handle from the mrx housing can cause the mrx to fall, potentially injuring the patient or user. in addition, a delay of therapy could occur if the device is damaged by the impact.
  • Action
    A hardware upgrade will be provided free of charge for all units affected by this issue. Customers are advised to continue to use their MRx prior to receiving the hardware upgrade. If one or both sides of the handle are found to have separated from the MRx housing, continue to treat the patient per existing protocols. Do not use the handle to carry the MRx. The MRx can be carried in another manner. For example, the MRx shoulder strap or bed rail hook can be used if available on the unit.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • Model / Serial
    Philips HeartStart MRx Monitor/Defibrillator All Models that received an M4760A Handle and Cap Plate Upgrade shipped before 2010ARTG number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA