International safety notice
Operating time after loading new dry batteries as stated in the instruction manual (Leocore S: 600 hours/Leocore D: 500 hours) We have decided to voluntarily recall the product because we have confirmed cases where the product does not meet the requirements.
Japan / PMDA Recalls · JPN · Nov 5, 2021
Key facts
| Title | Operating time after loading new dry batteries as stated in the instruction manual (Leocore S: 600 hours/Leocore D: 500 hours) We have decided to voluntarily recall the product because we have confirmed cases where the product does not meet the requirements. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Invasive external cardiac pacemaker Sales name: (1) Leocore S (2) Leocore D |
| Manufacturer | Biotronic Japan Co., Ltd. |
| Models | 61111725, 61109377, 61111562, 61111912, 61111262, 61111837, 61111647, 61111724, 61111696, 61111705, 61111855, 61111967 and 213 more |
| Date | Nov 5, 2021 |
| 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