International safety notice
A foreign manufacturer that is a consolidated subsidiary of our company stated, ``We have confirmed two cases in which chest compressions stopped working while using this device.'' I received a report saying that. It turns out that it happens.
Japan / PMDA Recalls · JPN · Jul 23, 2024
Key facts
| Title | A foreign manufacturer that is a consolidated subsidiary of our company stated, ``We have confirmed two cases in which chest compressions stopped working while using this device.'' I received a report saying that. It turns out that it happens. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Electric cardiopulmonary resuscitator Brand name: Automatic heart massage device RMU series |
| Manufacturer | Nihon Kohden Industries Co., Ltd. |
| Models | 502000946, 502000225, 502000932, 502000250, 502000938, 502000945, 502000944, 502000934, 502000245, 502000224, 502000212, 502000958 and 12 more |
| Date | Jul 23, 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