# FDA recall Z-3232-2017

> **Sorin Group Italia SRL - CRF** · Class II · device recall initiated 2017-07-24.

## Product

Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, 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 tachycardia (VT).

## Reason for recall

There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-3232-2017
- **Recalling firm:** Sorin Group Italia SRL - CRF
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-24
- **Report date:** 2017-10-04
- **Termination date:** 2024-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saluggia, VC, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3232-2017

## Citation

> AI Analytics. FDA recall Z-3232-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-3232-2017. Source: US FDA. Licensed CC0.

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