International safety notice
An overseas manufacturer has issued the following three problems due to a software bug built into the Fabian HFO series (*). There have been reports that this may occur. (2) When using HFO mode, the "circuit disconnection" alarm does not occur when the flow sensor and ET tube become disconnected. There is a risk. The overseas manufacturer will recall the products and update them to improved (*) software. In response to this, we have decided to voluntarily recall the affected products distributed in Japan. (*) Also, the above two products, Fabian Evolution and Fabian NIV, from overseas manufacturers. Additional information that the software will be recalled and updated to an improved version due to the possibility of the problem described in (3) occurring. had. In response to this, we have decided to voluntarily recall two products currently distributed in Japan.
Japan / PMDA Recalls · JPN · Aug 13, 2021
Key facts
| Title | An overseas manufacturer has issued the following three problems due to a software bug built into the Fabian HFO series (*). There have been reports that this may occur. (2) When using HFO mode, the "circuit disconnection" alarm does not occur when the flow sensor and ET tube become disconnected. There is a risk. The overseas manufacturer will recall the products and update them to improved (*) software. In response to this, we have decided to voluntarily recall the affected products distributed in Japan. (*) Also, the above two products, Fabian Evolution and Fabian NIV, from overseas manufacturers. Additional information that the software will be recalled and updated to an improved version due to the possibility of the problem described in (3) occurring. had. In response to this, we have decided to voluntarily recall two products currently distributed in Japan. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Neonatal/pediatric ventilator Sales name: (1) Fabian HFO series (2)Fabian Evolution(*) (3) Fabian NIV(*) |
| Manufacturer | Air Water Co., Ltd. |
| Models | AT-04393, AN-04173, AT-04660, AH18GC-00816, AH18LD-01410, AH18IC-00878, AT-04156, AT-04525, AT-04452, AT-04661, AT-04696, AN-03024 and 234 more |
| Date | Aug 13, 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