International safety notice
In our company's sales name "Parapack Plus", when the operation mode is switched to "ventilation" mode, human breathing It became clear that a continuous positive pressure gas flow could occur instead of the intended ventilation cycle. In response to this, we provided information in February 2024. We will provide information on precautions for use to ensure your safety. We would like to inform you that we will provide information. Now that we are ready to replace the parts with countermeasures, we will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Sep 11, 2024
Key facts
| Title | In our company's sales name "Parapack Plus", when the operation mode is switched to "ventilation" mode, human breathing It became clear that a continuous positive pressure gas flow could occur instead of the intended ventilation cycle. In response to this, we provided information in February 2024. We will provide information on precautions for use to ensure your safety. We would like to inform you that we will provide information. Now that we are ready to replace the parts with countermeasures, we will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: portable artificial respirator Sales name: Parapack Plus |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 2012021, 2010058, 1807066, 1710126, 2301110, 1905149, 1808092, 2209087, 1601371, 1704066, 1702102, 1703085 and 1955 more |
| Date | Sep 11, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 100–999 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