International safety notice
Common names: (1) Automatic implantable cardioverter defibrillator (2) Implantable biventricular pacing pulse generator with defibrillation function Brand name: (1)Cobalt MRI ICD series (2)Cobalt MRI CRT-D series
Japan / PMDA Recalls · JPN · Aug 10, 2022
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common names: (1) Automatic implantable cardioverter defibrillator (2) Implantable biventricular pacing pulse generator with defibrillation function Brand name: (1)Cobalt MRI ICD series (2)Cobalt MRI CRT-D series |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | RTC604634S, RTG601114S, RTC611552S, RSM606501S, RTG601110S, RSM603707S, RTC608149S, RSM601715S, RSM602307S, RTC603166S, RTC601203S, RSM602592S and 8764 more |
| Date | Aug 10, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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