Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18685 |
| Brand Name: | Topcon 3D Optical Coherence Tomography 3D OCT-1 Maestro systems |
| Model: | TOP-470109800 |
| Affected: | Serial number range: 105104 to 105701 |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Topcon Corporation |
| 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 type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/6/2015 |
