International safety notice
Cobalt MRI ICD series and Cobalt MRI CRT-D series from overseas manufacturers Insufficient energy (approximately 79% of the set energy) due to the short circuit protection function (SCP) being activated intermittently by We have received notification that high voltage treatment may be performed at Therefore, overseas manufacturers will voluntarily recall unused target products that were shipped before the introduction of screening tests. Did.
Japan / PMDA Recalls · JPN · Jun 23, 2022
Key facts
| Title | Cobalt MRI ICD series and Cobalt MRI CRT-D series from overseas manufacturers Insufficient energy (approximately 79% of the set energy) due to the short circuit protection function (SCP) being activated intermittently by We have received notification that high voltage treatment may be performed at Therefore, overseas manufacturers will voluntarily recall unused target products that were shipped before the introduction of screening tests. Did. |
|---|---|
| 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 | RTC601239S, RSD600774S, RSD600665S, RTC601154S, RTD600925S, RSD604419S, RTC609397S, RSC600600S, RSM606871S, RSM603644S, RSM606425S, RSL600877S and 6948 more |
| Date | Jun 23, 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