Events

Recall of Switch Point Infinity 3 (Operating Room Management System)

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-2015-RN-01190-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-12-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01190-1
  • 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 for sources utilising s-video and composite inputs, phase alternating line (pal) signals appear with jagged edges on all diagonal lines resulting in poor video quality. the potential hazard associated with this failure is a pal signal used with s-video or composite input that produces an image that is not clear and free of artefacts.
  • Action
    A Stryker Technical Service Representative will coordinate the update of affected devices. The update will correct the poor video quality as well as support for additional PAL resolution. This action has been closed-out on 29/08/2016.

Device

Switch Point Infinity 3 (Operating Room Management System)
  • Model / Serial
    Switch Point Infinity 3 (Operating Room Management System)Catalogue Number: 0678001000All serial numbers affectedARTG Number: 232446
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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