Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1395-2017

October 25, 2016

Class II

Product summary

Firm
MED-EL Elektromedizinische Gereate, Gmbh
Event
Event 76503
Status
Terminated
Classification
Class II
Quantity
538 units
Official record key
device-enforcement:Z-1395-2017

Official wording

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

Code information: Part No. 32291, Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50); Part No. 32292, Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50); Part No. 32293, Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50); Part No. 32294, Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50); Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and Part No. 32296, Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50).

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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