Class II — Sorin Group Italia SRL - CRF
| Recalling firm | SORIN GROUP ITALIA S.R.L |
|---|---|
| Registered facility | SORIN GROUP ITALIA S.R.L (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take. |
| Product | Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, 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 at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachy… |
| Quantity | 125 units |
| Distribution | US Nationwide Distribution |
| Initiated | 2017-07-24 |
| Classified | 2017-09-27 |
| Terminated | 2024-01-29 |
| Recall number | Z-3228-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sorin Group Italia SRL - CRF (Z-3228-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77983/
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