Recall Z-0750-2013— Envoy Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Envoy Medical Corporation, initiated 2013-01-09, terminated 2013-04-09. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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
- Envoy Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-09
- Terminated
- 2013-04-09
- Firm location
- Saint Paul, MN, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.