International safety notice
General name: Implantable cardiac pacemaker Sales name: (1)Ashrity MRI (2) Endurance MRI (3) Zenex (4) Zenex MRI (5) Zenas (6) Zenas MRI
Japan / PMDA Recalls · JPN · Feb 19, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General name: Implantable cardiac pacemaker Sales name: (1)Ashrity MRI (2) Endurance MRI (3) Zenex (4) Zenex MRI (5) Zenas (6) Zenas MRI |
| Manufacturer | Abbott Medical Japan LLC |
| Models | 9604660, 9536558, 9663631, 9654516, 9635895, 9628497, 9674058, 9668881, 9611644, 9687859, 9628303, 9595037 and 3765 more |
| Date | Feb 19, 2025 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
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