Events

Recall of Allura Systems: Field extensions Vascular R7.6

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-2015-RN-00105-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00105-1
  • 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
    Philips has received customer feedback where the monitor ceiling suspension (mcs) system fell to its lowest position. in this specific occasion it collided with the table top. the investigation initiated concluded that the cause of the failure was an assembly error of the actuator of the mcs. when the monitor ceiling suspension falls to its lowest position there is a possibility it might collide with patient or personnel in the room or with other equipment in close proximity of the mcs.
  • Action
    Philips will replace all MCS actuators on affected devices. Until this action can be undertaken straps being fitted around the MCS to prevent the monitors from falling down in the event that the actuator fails. In order to avoid any risk for patients, users or bystanders are recommended the following until the containment action has been implemented: - Do not position or move the Monitor Ceiling Suspension above the patient. - Do not allow staff to stand under or close to the Monitor Ceiling Suspension. Additionally avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users. This action has been closed-out on 03/08/2016.

Device

Allura Systems: Field extensions Vascular R7.6

Manufacturer

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