International safety notice
For neonatal flow sensors with a specific serial number, an overseas manufacturer has issued a message saying ``Please calibrate the flow sensor.'' We have received reports that alarms related to flow sensor calibration may occur, such as " As a result of our investigation, we have received a report stating that we have decided to recall the product because we cannot deny the occurrence of a similar event. We have also decided to voluntarily recall the affected products distributed in Japan.
Japan / PMDA Recalls · JPN · Nov 14, 2024
Key facts
| Title | For neonatal flow sensors with a specific serial number, an overseas manufacturer has issued a message saying ``Please calibrate the flow sensor.'' We have received reports that alarms related to flow sensor calibration may occur, such as " As a result of our investigation, we have received a report stating that we have decided to recall the product because we cannot deny the occurrence of a similar event. We have also 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) Infant ventilator SLE6000 (2) Infant ventilator SLE5000 series |
| Manufacturer | TKB Co., Ltd. |
| Models | 2200443A, 05-SMP, 2300262A, 2201119A, 2300167A, N5402, 2200456A, 2300093A, 1026696, N5301, 2200457A |
| Date | Nov 14, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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