International safety notice
During additional in-house software verification, we found that frequencies exceeding those reported were found to occur in the item specifications of the certificate. Thing that it was. Specifically, select Needle mode in program LOAD from HIGH mode, and select a treatment mode other than the selected mode. It has been discovered that it is possible to set a frequency exceeding 100Hz, so we will modify the software and recall the software.
Japan / PMDA Recalls · JPN · Jul 30, 2024
Key facts
| Title | During additional in-house software verification, we found that frequencies exceeding those reported were found to occur in the item specifications of the certificate. Thing that it was. Specifically, select Needle mode in program LOAD from HIGH mode, and select a treatment mode other than the selected mode. It has been discovered that it is possible to set a frequency exceeding 100Hz, so we will modify the software and recall the software. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: low-frequency therapy device, needle-electrode low-frequency therapy device Sales name: Esprit PG-1601 |
| Manufacturer | Ito High Frequency Co., Ltd. |
| Models | 202403900035, 202404900019, 202406900032, 202404900009, 202403900032, 202404900033, 202403900027, 202406900039, 202404900025, 202406900031, 202406900014, 202406900001 and 128 more |
| Date | Jul 30, 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