Events

Rappel de Spot Vision Screener 100 with software version up to and including 3.0.01.07

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Welch Allyn Australia Pty Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00138-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-28
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00138-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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