International safety notice
Common names: (1) (2) Automatic implantable cardioverter defibrillator (3) (4) Implantable biventricular pacing pulse generator with defibrillation function generator Sales name: (1) Galant ICD (2) Neutrino NxT ICD (3) Galant HF (4) Neutrino NxT HF
Japan / PMDA Recalls · JPN · Aug 21, 2023
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common names: (1) (2) Automatic implantable cardioverter defibrillator (3) (4) Implantable biventricular pacing pulse generator with defibrillation function generator Sales name: (1) Galant ICD (2) Neutrino NxT ICD (3) Galant HF (4) Neutrino NxT HF |
| Manufacturer | Abbott Medical Japan LLC |
| Models | 810010622, 111002068, 111006514, 810004337, 810009380, 810011800, 111012685, 111003745, 111025960, 111004342, 810018089, 111004478 and 890 more |
| Date | Aug 21, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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