International safety notice
Medical institutions have complained that the device restarts automatically during use. We have identified an issue with the hardware that could cause a restart when recording history after performing a patient procedure. Therefore, we are conducting a voluntary recall of products that have this version of software installed. vinegar.
Japan / PMDA Recalls · JPN · Dec 25, 2024
Key facts
| Title | Medical institutions have complained that the device restarts automatically during use. We have identified an issue with the hardware that could cause a restart when recording history after performing a patient procedure. Therefore, we are conducting a voluntary recall of products that have this version of software installed. vinegar. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Ablation electrosurgical unit Sales name: Top Region Generator TLG-20 |
| Manufacturer | Top Co., Ltd. |
| Models | UT10127, TLG-20, UT10130, 13885, UT10172, UT10111, UT10136, UT10174, UT10175, UT10105, UT10113, UT10101 and 2 more |
| Date | Dec 25, 2024 |
| 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