International safety notice
On July 5, 2021, we received a report of a problem that the oxygen concentration of this device had decreased. As a result of the investigation, it was determined that the problem was caused by a manufacturing problem (inappropriate work by a specific worker) in the compressor, which is a component of this equipment. I was thinking of doing it. Although I thought it was high, I completely excluded the possibility that a similar problem would occur with the compressor that the worker was involved in manufacturing. Since we cannot deny this, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Jun 22, 2022
Key facts
| Title | On July 5, 2021, we received a report of a problem that the oxygen concentration of this device had decreased. As a result of the investigation, it was determined that the problem was caused by a manufacturing problem (inappropriate work by a specific worker) in the compressor, which is a component of this equipment. I was thinking of doing it. Although I thought it was high, I completely excluded the possibility that a similar problem would occur with the compressor that the worker was involved in manufacturing. Since we cannot deny this, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Oxygen concentrator Sales name: High Sanso Portable αII |
| Manufacturer | Teijin Pharma Co., Ltd. |
| Models | HH185X0010, HH18CX0063, HH181X0022, HH182X0026, HH175X0054, HH214X0002, HH164X0122, HH171X0014, HH169X0013, HH181X0040, HH17AX0006, HH194X0055 and 256 more |
| Date | Jun 22, 2022 |
| 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