FDA-Device2017-03-08Class II
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.
MED-EL Elektromedizinische Gereate, Gmbh
Hazard
Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.
Sold states
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.
Affected count
538 units
Manufactured in
Furstenweg 77a, N/A, Innsbruck, N/A, Austria
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1395-2017Don't want to check this manually?
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