International safety notice
For this product, the module unit (hereinafter referred to as module) is inserted into the base unit (hereinafter referred to as base) by a medical institution. When I was using the module in a locked state (AC drive), the module switched to standalone drive (battery drive). We have received a report that a collision has occurred. As a result of the investigation, it was thought that the cause was a failure to recognize the incomplete docking state of the base and module. We will implement a voluntary recall to change the docking mechanism of the base.
Japan / PMDA Recalls · JPN · Sep 26, 2023
Key facts
| Title | For this product, the module unit (hereinafter referred to as module) is inserted into the base unit (hereinafter referred to as base) by a medical institution. When I was using the module in a locked state (AC drive), the module switched to standalone drive (battery drive). We have received a report that a collision has occurred. As a result of the investigation, it was thought that the cause was a failure to recognize the incomplete docking state of the base and module. We will implement a voluntary recall to change the docking mechanism of the base. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Centrifugal pump drive for extracorporeal circulation devices Brand name: JMS Blood Pump System |
| Manufacturer | JMS Co., Ltd. |
| Models | 00003, WJMS00002, 00014, 00012, 00041 |
| Date | Sep 26, 2023 |
| 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