Events

Recall of PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling Suspension

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia Pty 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-00050-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00050-1
  • 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
    Maquet received complaints of grinding on double (2 arms) or triple suspensions (3 arms), with paint possibly chipping from the junction between the 2 arms.Paint chips or particles can fall down from the suspended lights. this may happen during surgical procedures, in which case, paint chips may fall inside the surgical field of a patient.
  • Action
    A Maquet technical specialist will arrange to inspect all potentially affected devices. Where grinding arms are detected a replacement of the suspension will be provided. This action has been closed-out on 05/09/2016.

Device

PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling Suspension
  • Model / Serial
    PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling SuspensionUnits manufactured between March 2012 and July 2014ARTG Number: 162037
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA