Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
Sorin Group Italia SRL is recalling Platinium DR 1510 ICDs due to a possibility of overconsumption following ElectroStatic Discharge (ESD) during implant surgery or MRI scans.
- Product
- Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are
- Category
- Medical Device
- Distribution
- Distributed nationwide