International safety notice
On August 3, 2020, we received a complaint that an alarm indicating an abnormality in the battery of this device was activated. As a result of the investigation, it was determined that this problem was caused by a manufacturing problem (solder failure) in the power supply board, which is a component of this device. It turned out that. After checking with the power supply board manufacturer, all power supply boards manufactured since the start of production have contained solder defects. We have come to the conclusion that we cannot completely deny the possibility that We have decided to carry out a voluntary recall as there is a possibility that the system may shut down without issuing a warning.
Japan / PMDA Recalls · JPN · Oct 30, 2023
Key facts
| Title | On August 3, 2020, we received a complaint that an alarm indicating an abnormality in the battery of this device was activated. As a result of the investigation, it was determined that this problem was caused by a manufacturing problem (solder failure) in the power supply board, which is a component of this device. It turned out that. After checking with the power supply board manufacturer, all power supply boards manufactured since the start of production have contained solder defects. We have come to the conclusion that we cannot completely deny the possibility that We have decided to carry out a voluntary recall as there is a possibility that the system may shut down without issuing a warning. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Oxygen concentrator Sales name: High Sanso Portable αIII |
| Manufacturer | Teijin Pharma Co., Ltd. |
| Models | JD237X0019, JD237X0031, JD239X0030, JD237X0004, JD238X0037, JD239X0061, JD238X0018, JD239X0074, JD239X0064, JD236X0027, JD238X0035, JD237X0070 and 277 more |
| Date | Oct 30, 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