International safety notice
AR that is outside the approved range in the options of the ligation mode (ligation function, Tissue Seal PLUS function) of the product Since we confirmed that the product is equipped with the C Seal function, we have decided to implement a voluntary recall to disable the function.
Japan / PMDA Recalls · JPN · Jul 27, 2023
Key facts
| Title | AR that is outside the approved range in the options of the ligation mode (ligation function, Tissue Seal PLUS function) of the product Since we confirmed that the product is equipped with the C Seal function, we have decided to implement a voluntary recall to disable the function. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: therapeutic electrosurgical device Brand name: BOWA high frequency electrosurgical device ARC400 |
| Manufacturer | TKB Co., Ltd. |
| Models | ARC400L, 40003677 |
| Date | Jul 27, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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