International safety notice
As a result of research at overseas manufacturers, all Trilogy Evo series equipped with an oxygen mixing module (Trilo When using FiO2 (ratio of inspired oxygen) set to 70% or higher in G-Evo O2), the oxygen concentration supplied It was confirmed that there is a possibility that the value is less than the allowable error range of -5%. Even if an O2 sensor (a sensor for measuring FiO2 values) is used, the O2 sensor values may not actually be supplied. It was confirmed that there is a possibility that the FiO2 value may be higher than the FiO2 value. It may vary depending on lung resistance, particle filter use, or circuit configuration. The overseas manufacturer will provide information about the device to users and update the software. Therefore, we have decided to take the same action as a voluntary recall in Japan.
Japan / PMDA Recalls · JPN · Aug 1, 2024
Key facts
| Title | As a result of research at overseas manufacturers, all Trilogy Evo series equipped with an oxygen mixing module (Trilo When using FiO2 (ratio of inspired oxygen) set to 70% or higher in G-Evo O2), the oxygen concentration supplied It was confirmed that there is a possibility that the value is less than the allowable error range of -5%. Even if an O2 sensor (a sensor for measuring FiO2 values) is used, the O2 sensor values may not actually be supplied. It was confirmed that there is a possibility that the FiO2 value may be higher than the FiO2 value. It may vary depending on lung resistance, particle filter use, or circuit configuration. The overseas manufacturer will provide information about the device to users and update the software. Therefore, we have decided to take the same action as a voluntary recall in Japan. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Artificial respirator for adults Sales name: Trilogy Evo series |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | H29460649B10D, H358104989449, H29336849D009, H30211635C272, H348433810019, H296831008B8A, H3602538520DC, H29626024863D, H296814694250, H29702523AB70, H286427594A74, H30294923C02C and 4189 more |
| Date | Aug 1, 2024 |
| 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