| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00517-1 |
| Product Name/Description |
TOPCON – 3D Optical Coherence Tomography 3D OCT-1 MAESTRO machines
Product code: TOP-470109800
ARTG Number: 135436 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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.
This action has been closed out on the 26/10/2018. |
| Contact Information |
02 9972 8351 - Device Technologies |