International safety notice
Data measured using the patch-type electroencephalogram HARU-2 updated to firmware version 2.002 is displayed at regular intervals. We have received a report that the product is contaminated with As a result, a shift occurs in the starting position of writing to the microcontroller's memory, and writing is performed at regular intervals starting from the shifted point. It was discovered that a defect had occurred. We have decided to carry out a voluntary recall due to the occurrence of writing errors that make it impossible to analyze correctly. Ta.
Japan / PMDA Recalls · JPN · Jun 20, 2023
Key facts
| Title | Data measured using the patch-type electroencephalogram HARU-2 updated to firmware version 2.002 is displayed at regular intervals. We have received a report that the product is contaminated with As a result, a shift occurs in the starting position of writing to the microcontroller's memory, and writing is performed at regular intervals starting from the shifted point. It was discovered that a defect had occurred. We have decided to carry out a voluntary recall due to the occurrence of writing errors that make it impossible to analyze correctly. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: telemetry electroencephalograph Brand name: Patch type electroencephalogram HARU-2 |
| Manufacturer | PGV Co., Ltd. |
| Models | 2210038, 2210037, 2210054, 2210033, 2210046, 2206031, 2206023, 2203023, 2203018, 2203021, 2205004, 2205010 and 47 more |
| Date | Jun 20, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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