International safety notice
Due to a notification from a foreign manufacturer, some of these products may have problems due to malfunction of the control board, resulting in unexpected It was discovered that there was a device that could shut down or cause the ventilator to lose ventilation. Therefore, we have decided to voluntarily recall the equipment with the relevant serial number.
Japan / PMDA Recalls · JPN · Jun 24, 2021
Key facts
| Title | Due to a notification from a foreign manufacturer, some of these products may have problems due to malfunction of the control board, resulting in unexpected It was discovered that there was a device that could shut down or cause the ventilator to lose ventilation. Therefore, we have decided to voluntarily recall the equipment with the relevant serial number. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: General-purpose artificial respirator Sales name: All-in-one VOCSN ventilator |
| Manufacturer | Skynet Co., Ltd. |
| Models | 113096, PRT-00973-100, PRT-00853-100, 113598, 112929 |
| 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