MED-EL Elektromedizinische Gereate, Gmbh recalls SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack

Recalled March 8, 2017 · FDA recall Z-1395-2017 · MED-EL Elektromedizinische Gereate

Hazard

Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing. · FDA Class II

Units

538 units

Sold at

Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.

Description

Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

Product

SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

Manufacturer(s)

MED-EL Elektromedizinische Gereate, Gmbh

Made in

Austria

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →