Events

Recall of SwitchPoint Infinity 3 - SPI3 (central point of control and integration of ancillary compatible equipment, audio, video, and data routing )

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-2014-RN-00988-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-09-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00988-1
  • 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 likelihood of audio loss, intermittent audio, or distorted audio with the spi3.
  • Action
    The Stryker Representative will inspect and replace the audio board/system with the latest version. This action has been closed-out on 06/06/2016.

Device

SwitchPoint Infinity 3 - SPI3 (central point of control and integration of ancillary compatible e...
  • Model / Serial
    SwitchPoint Infinity 3 - SPI3 (central point of control and integration of ancillary compatible equipment, audio, video, and data routing )Catalogue Number: 0678001000ARTG Number: 188933
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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