Events

Recall of Specular Microscope SP-1P (non-invasive photographic microscope)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-00771-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00771-1
  • 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
    It has come to the attention of topcon corporation that during the analysis of large corneal endothelial cells captured by the “specular microscope sp-1p” the unit may provide higher than actual cell count. topcon corporation found that in some cases when an image with large corneal endothelial cells (approximate cell density 1,500 cells/mm2 or less) was analysed the cell density may be higher due to a smaller cell area. consequently, when an image with large corneal endothelial cells is analysed by the current auto-analysis software, it detects the core of the cell as a cell wall, hence one cell would be recognised as two or more cells.
  • Action
    Device Technologies is providing a software upgrade to improve the detection of large size cells. End users are advised to evaluate the examination result of the Specular Microscope SP-1P not only with the resulting cell count, but also by reviewing the captured image while awaiting the software upgrade. This action has been closed-out on 19/02/2016.

Device

Specular Microscope SP-1P (non-invasive photographic microscope)

Manufacturer

Device Technologies Australia Pty Ltd