International safety notice
We received one quality report from a medical institution in which the power went out and the product would not turn on while using the product. As a result, it was confirmed that the module in the power supply unit had poor solder compatibility (solder paste not melted). I did. It was determined that he had fallen and was unable to stand up. It was discovered that poor solder compatibility may have occurred due to manufacturing issues in fixed lots, so we have identified We will conduct a voluntary recall to inspect the power supply module of the product that used the power supply of the lot and replace it if necessary. We decided to implement it.
Japan / PMDA Recalls · JPN · Dec 19, 2024
Key facts
| Title | We received one quality report from a medical institution in which the power went out and the product would not turn on while using the product. As a result, it was confirmed that the module in the power supply unit had poor solder compatibility (solder paste not melted). I did. It was determined that he had fallen and was unable to stand up. It was discovered that poor solder compatibility may have occurred due to manufacturing issues in fixed lots, so we have identified We will conduct a voluntary recall to inspect the power supply module of the product that used the power supply of the lot and replace it if necessary. We decided to implement it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Balloon pump drive device for auxiliary circulation Sales name: IABP console ZUIRYU |
| Manufacturer | Zeon Medical Co., Ltd. |
| Models | DU4A13 |
| Date | Dec 19, 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