International safety notice
An overseas manufacturer reports that the device will not start or will not start due to insufficient soldering of one component on the power supply board. If you do a recall to replace these with a modified power supply board as it may shut down without warning during use. I received a message. In response to this, we have decided to voluntarily recall the affected products distributed in Japan.
Japan / PMDA Recalls · JPN · May 6, 2021
Key facts
| Title | An overseas manufacturer reports that the device will not start or will not start due to insufficient soldering of one component on the power supply board. If you do a recall to replace these with a modified power supply board as it may shut down without warning during use. I received a message. In response to this, we have decided to voluntarily recall the affected products distributed in Japan. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Neonatal/pediatric ventilator Sales name: (1) Fabian HFO series (2) Fabian Evolution |
| Manufacturer | Air Water Co., Ltd. |
| Models | AN11ED-1122, AN11ED-1121, AN11ED-1123, AN12HD-1289, AH18LC-00957, AK-00291, AK-00293, AN11ED-1125, AK-00141, AK-00292, AN11ED-1124, AH18LC-00962 and 13 more |
| Date | May 6, 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