Recall Z-1395-2017— MED-EL Elektromedizinische Gereate, Gmbh
Class II · Terminated
Class II FDA medical device recall by MED-EL Elektromedizinische Gereate, Gmbh, initiated 2016-10-25, terminated 2017-04-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing..
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-25
- Terminated
- 2017-04-04
- Firm location
- Innsbruck, N/A, Austria
Product description
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.
Reason for recall
Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.