Events

Recall of Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2017-RN-00455-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00455-1
  • 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
    Stryker has become aware that there is a remote likelihood that the eds light suspension, central axis may have an insufficiently assembled joint in the suspension. if the eds light suspension, central axis falls, it could potentially cause serious injuries to health care providers and/or patients. to date, there have been no adverse events reported to stryker for this issue worldwide.
  • Action
    A Stryker Technician will contact users to organise a time to perform an inspection of the product. If a correction is required the central axis will be replaced. In the interim, if the product malfunctions, users are to immediately discontinue its use and contact Stryker immediately.

Device

Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions
  • Model / Serial
    Visum LED Surgical Lighting system - EDS Light Suspensions, Central Axis EDS Light Suspensions Item Numbers (Serial Numbers):0682-001-566 (15K002818, 15K002498, 15K002518, 15K002508) 0682-400-142 (15L004128)0682-400-148I (16C001798)0682-001-567I (15L006528)ARTG Number: 118878
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA