International safety notice
During an in-house bench test at a foreign manufacturer, one of the two processors that monitors each other during ventilation operations. If the processor goes into forced shutdown, the ventilator may stop ventilation without issuing an alarm. An exceptional condition has been discovered. As a precaution, we recommend that you perform a mandatory firmware upgrade to correct this potential issue. We have received a report that the product with the serial number in question has been recalled.
Japan / PMDA Recalls · JPN · Apr 12, 2022
Key facts
| Title | During an in-house bench test at a foreign manufacturer, one of the two processors that monitors each other during ventilation operations. If the processor goes into forced shutdown, the ventilator may stop ventilation without issuing an alarm. An exceptional condition has been discovered. As a precaution, we recommend that you perform a mandatory firmware upgrade to correct this potential issue. We have received a report that the product with the serial number in question has been recalled. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: General-purpose artificial respirator Sales name: (1) Smart ventilator Vivo 45 (2) Smart ventilator Vivo 45LS |
| Manufacturer | Chest Co., Ltd. |
| Models | K320231, D010218, K370442, K180654, M090503, Y410263, D400096, D280665, K430124, K430105, Y400005, D400807 and 2020 more |
| Date | Apr 12, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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