International safety notice
"3D fundus image imaging device 3D OCT-1 and 3D OCT-1 Type: Maestro2 ("Type ：Maestro2" is the catalog number)" The parts that make up the product (galvano mirror unit) are the supplier. It was changed in However, we released the modified parts as service parts, but our company, which is the manufacturer and distributor, is using 3D OCT. -1 Due to a delay in notifying the repair company that the application confirmation for 1 has not been completed, the repair company 3D OCT-1 was repaired using the parts concerned. The above fact has recently come to light, and the repair was carried out despite the flaw in the instructions from our company, the manufacturer and distributor. Therefore, it was determined that the product could not fulfill its obligations under the Pharmaceutical and Medical Devices Act as a manufacturer and distributor, and could not be applied as a repair part. Until this is confirmed, we have decided to issue a voluntary recall and ask customers to use alternative products.
Japan / PMDA Recalls · JPN · Nov 10, 2022
Key facts
| Title | "3D fundus image imaging device 3D OCT-1 and 3D OCT-1 Type: Maestro2 ("Type ：Maestro2" is the catalog number)" The parts that make up the product (galvano mirror unit) are the supplier. It was changed in However, we released the modified parts as service parts, but our company, which is the manufacturer and distributor, is using 3D OCT. -1 Due to a delay in notifying the repair company that the application confirmation for 1 has not been completed, the repair company 3D OCT-1 was repaired using the parts concerned. The above fact has recently come to light, and the repair was carried out despite the flaw in the instructions from our company, the manufacturer and distributor. Therefore, it was determined that the product could not fulfill its obligations under the Pharmaceutical and Medical Devices Act as a manufacturer and distributor, and could not be applied as a repair part. Until this is confirmed, we have decided to issue a voluntary recall and ask customers to use alternative products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Ocular imaging device Brand name: 3D fundus imaging device 3D OCT-1 |
| Manufacturer | Topcon Co., Ltd. |
| Models | ，101610, 101282, ，101663, ，107856, ，101674 |
| Date | Nov 10, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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