THERANICA BIOELECTRONICS LTD: Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

Hazard

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

Details from the source

Reason for recall: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. Distribution: The product's entry point to the US is a 3PL warehouse from which it is being shipped to DME distributors or specialty pharmacy who perform the shipment to the end-user Quantity: 11,886 units Lot/code info: Model/Catalog Number: FGD000100. UDI: 01072900175781181125120221NI2544-0300673 Software Version: FW Version 4.1.2.0, App version 7.28.0.11 GTIN: 7290017578118. Serial Number: NI2544-0300673.

UPC codes

7290017578118

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.