International safety notice
Fundus tomography scanning scan pattern of fundus radial scan 9m using "3D fundus imaging device DRI OCT Triton" When shooting with m, the following problem occurs in the analysis software (FastMap Ver.11.01) included with the product. It turns out that it will survive. (1) Fundus radial scan 9mm data is not displayed in the data list. (2) Unable to transition from shooting preview screen to View screen. (3) Reports cannot be exported from the shooting preview or report screen. The above facts have recently come to light, and the function of the fundus radial scan 9mm described in the manufacturing and sales certificate cannot be used. It has been determined that failure to do so would affect the effectiveness of the product as it would result in a deviation from the product specifications for which the product was applied for manufacturing and sales certification. Ta. The sales company or our employees visit the relevant facility and confirm the products used. Reinstall the software (Ver.11.01.1) with bugs fixed, and install the software (Ver.11.01) that has already been delivered. We have decided to carry out collection work to replace the media with one (Ver.11.01.1).
Japan / PMDA Recalls · JPN · May 28, 2024
Key facts
| Title | Fundus tomography scanning scan pattern of fundus radial scan 9m using "3D fundus imaging device DRI OCT Triton" When shooting with m, the following problem occurs in the analysis software (FastMap Ver.11.01) included with the product. It turns out that it will survive. (1) Fundus radial scan 9mm data is not displayed in the data list. (2) Unable to transition from shooting preview screen to View screen. (3) Reports cannot be exported from the shooting preview or report screen. The above facts have recently come to light, and the function of the fundus radial scan 9mm described in the manufacturing and sales certificate cannot be used. It has been determined that failure to do so would affect the effectiveness of the product as it would result in a deviation from the product specifications for which the product was applied for manufacturing and sales certification. Ta. The sales company or our employees visit the relevant facility and confirm the products used. Reinstall the software (Ver.11.01.1) with bugs fixed, and install the software (Ver.11.01) that has already been delivered. We have decided to carry out collection work to replace the media with one (Ver.11.01.1). |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Ocular imaging device Brand name: 3D fundus imaging device DRI OCT Triton |
| Manufacturer | Topcon Co., Ltd. |
| Models | ，850004, ，850009, ，850002, ，850005, ，850008, ，850006, ，850013, ，350028, ，35000, ，850007, ，350003, ，350005 and 6 more |
| Date | May 28, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1