Events

Recall of Spot Vision Screener 100 with software version up to and including 3.0.01.07

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Welch Allyn Australia Pty Limited.

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-2018-RN-00138-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00138-1
  • 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 device is not used or charged every five months, the coin cell battery that maintains the system clock may become depleted. once the coin cell battery has depleted, the system clock will reset to a date in the past (date of the last installed software release for example). this may cause the patient age to be calculated incorrectly. please note, the patient age is used by the spot vision screener 100 to determine referral criteria for certain screening conditions–specifically anisometropia, myopia, astigmatism and hyperopia. an incorrect patient age could result in an incorrect (either under or over) referral recommendation.
  • Action
    Welch Allyn is recommending users review new software releases and determine if the device should be updated. Software updates can be downloaded at www.welchallyn.com.au. In the interim, users are advised to refer to the additional instructions to re set the system clock if the issue occurs.

Device

Spot Vision Screener 100 with software version up to and including 3.0.01.07
  • Model / Serial
    Spot Vision Screener 100 with software version up to and including 3.0.01.07Model Number: Model VS100ARTG Number: 293205Welch Allyn Australia - Visual function analyser
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited