International safety notice
The lithium-ion battery for the autopulse artificial resuscitation system has been fully charged overseas. Despite this, there have been reports of the device not starting up. As a result of the investigation, it was determined that there is a possibility that this event may occur due to the semiconductor element used on the printed circuit board of the product with a specific serial number. As we have discovered that there is a problem, we are implementing a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Sep 26, 2022
Key facts
| Title | The lithium-ion battery for the autopulse artificial resuscitation system has been fully charged overseas. Despite this, there have been reports of the device not starting up. As a result of the investigation, it was determined that there is a possibility that this event may occur due to the semiconductor element used on the printed circuit board of the product with a specific serial number. As we have discovered that there is a problem, we are implementing a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Electric cardiopulmonary resuscitator Sales name: Autopulse artificial resuscitation system Model 100 V1.5 |
| Manufacturer | Asahi Kasei Sol Medical Co., Ltd. |
| Models | 08647, 8700-0752-03, 08606, 08640 |
| Date | Sep 26, 2022 |
| 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