Events

Recall of TOPCON – 3D Optical Coherence Tomography 3D OCT-1 MAESTRO machines

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-2015-RN-00517-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00517-1
  • 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
    In certain usage environments, when the 3d oct-1 is used over a prolonged period of time, dust can penetrate into the optical system and adhere to the surface of the lens. this dust accumulates gradually over time and this can cause a whitish shadow artefact to occur in centre of the image and potentially create a blurry background. if this occurs, the reduced image quality is an obvious anomaly noticed during clinical assessment which cannot be mistaken for patient pathology.
  • Action
    Topcon Corporation will perform a retrofit to block the penetration points to prevent dust from entering into the optical system. In order to do this, Device Technologies will organise the return of affected machines to the manufacturer for the upgrade. A loan unit will be provided for the site whilst their machine is being upgraded. The corrective retro-fit action will be performed in a systematic manner, over a period of time due to the limited number of loan units available. Although affected systems may not exhibit any evidence of this artefact, it is recommended that all units undergo this preventative measure. Customers may continue to use their machine as usual until a loan unit is available for the site.

Device

TOPCON – 3D Optical Coherence Tomography 3D OCT-1 MAESTRO machines

Manufacturer

Device Technologies Australia Pty Ltd