International safety notice
An investigation by an overseas manufacturer has confirmed that there is a possibility that electrode corrosion may occur due to moisture infiltration in the affected products. did. This product is a monitoring device that does not have a therapeutic function, and does not require remote monitoring or regular regular follow-up. It is possible to observe the operating status. We have decided to collect the used products.
Japan / PMDA Recalls · JPN · Jun 20, 2024
Key facts
| Title | An investigation by an overseas manufacturer has confirmed that there is a possibility that electrode corrosion may occur due to moisture infiltration in the affected products. did. This product is a monitoring device that does not have a therapeutic function, and does not require remote monitoring or regular regular follow-up. It is possible to observe the operating status. We have decided to collect the used products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Implantable electrocardiographic data recorder Brand name: Medtronic LINQII |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | RLB669481G, RLB474960G, RLB584090G, RLB472346G, RLB689710G, RLB410615G, RLB465567G, RLB701234G, RLB698677G, RLB552659G, RLB469489G, RLB616222G and 754 more |
| Date | Jun 20, 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