FDA DeviceClass IINotable

FDA Recall: Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App versi

Date: 2026-08-12
Brand: THERANICA BIOELECTRONICS LTD
Category: Medical Device
FDA Class: Class II

Description

Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

Hazard

Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

Remedy

11,886 units

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