International safety notice
At a medical institution, we have received a report that the LED pad for optical stimulation has stopped glowing and an error message has been displayed on the device side. Ta. It turned out that an error message appeared on the installation side and the device did not work properly. This phenomenon occurs when the connector gradually becomes loose by repeatedly connecting and disconnecting the LED pad or extension cord. vinegar. We will carry out a voluntary recall to re-tighten the connector section of the "Code". We will also carry out a voluntary recall of ``extension cords.''
Japan / PMDA Recalls · JPN · Mar 8, 2023
Key facts
| Title | At a medical institution, we have received a report that the LED pad for optical stimulation has stopped glowing and an error message has been displayed on the device side. Ta. It turned out that an error message appeared on the installation side and the device did not work properly. This phenomenon occurs when the connector gradually becomes loose by repeatedly connecting and disconnecting the LED pad or extension cord. vinegar. We will carry out a voluntary recall to re-tighten the connector section of the "Code". We will also carry out a voluntary recall of ``extension cords.'' |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Visual Evoked Response Stimulator Commercial name: LED light stimulation device LFS-101 |
| Manufacturer | Unique Medical Co., Ltd. |
| Models | P018-2103, E015-2211, 1068-2003, P023-2107, 1025-1805, E016-2211, 1034-1901, E010-2103, 1012-1712, 1029-1807, 1021-1803, 1007-1708 and 114 more |
| Date | Mar 8, 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