International safety notice
We received a report of a problem that the main battery of this device was emitting smoke. As a result of the investigation, there were no similar problems occurring in other devices of the same model, and we believe that there is a high possibility that this was an individual (single) event. However, the main battery was determined to have a "defective labeling" during the manufacturer's acceptance inspection, and after being returned to the battery manufacturer, it was repaired. It has been discovered that there is a history of At this time, it has not been determined that the repair was the cause of the smoke, but we have confirmed that the main battery has a history of repair. We have decided to recall the product because we cannot deny the possibility that a similar problem may occur.
Japan / PMDA Recalls · JPN · Jun 24, 2021
Key facts
| Title | We received a report of a problem that the main battery of this device was emitting smoke. As a result of the investigation, there were no similar problems occurring in other devices of the same model, and we believe that there is a high possibility that this was an individual (single) event. However, the main battery was determined to have a "defective labeling" during the manufacturer's acceptance inspection, and after being returned to the battery manufacturer, it was repaired. It has been discovered that there is a history of At this time, it has not been determined that the repair was the cause of the smoke, but we have confirmed that the main battery has a history of repair. We have decided to recall the product because we cannot deny the possibility that a similar problem may occur. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Oxygen concentrator Sales name: High Sanso Portable α |
| Manufacturer | Teijin Pharma Co., Ltd. |
| Models | HW208C0112, HW132X0063, HW182C0055, HW174C0010, HW208C0129, HW153C0027, HW186C0090, HW208C0144, HW182C0002, HW14BC0023, HW154C0010, HW208C0071 and 346 more |
| Date | Jun 24, 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