International safety notice
As a result of research at overseas manufacturers, all V60 ventilators provide power to the ventilator and alarm. A potential issue has been identified that may affect the main electrical circuit (35V rail). One of the following events may occur: 1) Both visual and audible alarms are activated and the ventilator is deactivated 2) Both visual and audible alarms are not activated and the ventilator stops working (silent shutdown) Replaced with a new power management board that is designed to sound an alarm in all events caused by this issue. Masu. We have completed providing information regarding this matter to the target facilities.
Japan / PMDA Recalls · JPN · May 15, 2024
Key facts
| Title | As a result of research at overseas manufacturers, all V60 ventilators provide power to the ventilator and alarm. A potential issue has been identified that may affect the main electrical circuit (35V rail). One of the following events may occur: 1) Both visual and audible alarms are activated and the ventilator is deactivated 2) Both visual and audible alarms are not activated and the ventilator stops working (silent shutdown) Replaced with a new power management board that is designed to sound an alarm in all events caused by this issue. Masu. We have completed providing information regarding this matter to the target facilities. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Artificial respirator for adults Sales name: V60 ventilator |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | 100190191, 100190097, 100388643, 100261118, 100054813, 100060222, 100291387, 100306501, 100333562, 100354444, 100019967, 100254567 and 6494 more |
| Date | May 15, 2024 |
| 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