Events

Recall of Stryker Standard Video Cart and Vision Mounting Arm

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-2013-RN-00976-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00976-1
  • 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
    If the tension screw present in the mounting yoke of the vision mounting arm is loose and the user applies excessive force during positioning, the user can push the monitor out of the yoke. this will cause the monitor to dislodge from the mounting arm and fall potentially impacting an operator or patient.
  • Action
    Stryker is advising users that a new screw and washer will be installed on all affected units to ensure the monitor is securely fastened to the mounting yoke. It is expected that this will be completed by April 2014.

Device

Stryker Standard Video Cart and Vision Mounting Arm
  • Model / Serial
    Stryker Standard Video Cart and Vision Mounting ArmCatalogue Numbers: 0240099011 (Video Cart), 0240099011I (Video Cart), 0240095200 (Mounting Arm) All lots affectedARTG Number: 106511
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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