International safety notice
When using this product, we have confirmed a problem where a higher than expected current flows on the board. It was discovered that certain parts mounted on the electronic board were different from the design. We have decided to carry out a voluntary recall to replace the board with a new one.
Japan / PMDA Recalls · JPN · May 7, 2024
Key facts
| Title | When using this product, we have confirmed a problem where a higher than expected current flows on the board. It was discovered that certain parts mounted on the electronic board were different from the design. We have decided to carry out a voluntary recall to replace the board with a new one. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Low frequency therapeutic device Sales name: Super Doctor AC6000 |
| Manufacturer | Cosmic EM Co., Ltd. |
| Models | 230006, 230342, 230057, 210471, 230368, 230359, 230012, 230114, 230390, 230403, 230394, 230187 and 455 more |
| Date | May 7, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 100–999 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