Company:Envoy Medical Corp
Date of Enforcement Report 2/6/2013
Class ll:
PRODUCT
Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. Part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer. Recall Number Z-0750-2013
REASON
Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.
RECALLING FIRM/MANUFACTURER
Envoy Medical Corporation, St Paul, MN on 1/9/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
44
DISTRIBUTION
Nationwide and Internationally
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