International safety notice
Due to a software glitch, the oronasal respiration waveform data recorded on the 1st day using the sleep evaluation device LS-140 was changed from the 2nd and 3rd day. It turned out that it was used for waveform display and measurement of the oronasal respiration waveform data on the day. Therefore, we will collect the software and replace it with improved software.
Japan / PMDA Recalls · JPN · Aug 5, 2021
Key facts
| Title | Due to a software glitch, the oronasal respiration waveform data recorded on the 1st day using the sleep evaluation device LS-140 was changed from the 2nd and 3rd day. It turned out that it was used for waveform display and measurement of the oronasal respiration waveform data on the day. Therefore, we will collect the software and replace it with improved software. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Program for sleep assessment devices Sales name: SAS measurement software LSA-1000 |
| Manufacturer | Fukuda Electronics Co., Ltd. |
| Models | 50000450, 50000001 |
| Date | Aug 5, 2021 |
| 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