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U.S. Department of Health and Human Services

Class 2 Device Recall Esteem Programmers

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 Class 2 Device Recall Esteem Programmers see related information
Date Posted January 30, 2013
Recall Status1 Terminated on April 09, 2013
Recall Number Z-0750-2013
Recall Event ID 63875
PMA Number P090018 
Product Classification Implant, hearing, active, middle ear, totally implanted - Product Code OAF
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.
Code Information Lot#
EMC0004011
EMC0004665
EMC0004114
EMC0004356
EMC0004639
EMC0004399
EMC0004922
EMC0004923
EMC0004989
EMC0004126
EMC0004310
EMC0004724
EMC0004967
EMC0004759
EMC0004235
EMC0004929
EMC0004234
EMC0004965
EMC0004932
EMC0004928
EMC0004969
EMC0004930
EMC0004844
EMC0004053


Lot#
EMC0003968
EMC0003985
EMC0003935
EMC0004028
EMC0004027
EMC0004376
EMC0004125
EMC0004303
EMC0004196
EMC0003852
EMC0004191
EMC0004286
EMC0004491
EMC0004594
EMC0004757
EMC0004510


Lot#
EMC0004304
EMC0004797



Lot#
EMC0003827
EMC0004233
Recalling Firm/
Manufacturer
Envoy Medical Corporation
5000 Township Parkway
Saint Paul MN 55110
651-361-8000
For Additional Information Contact
651-361-8000
Manufacturer 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.
FDA Determined
Cause 2
Software design
Action Envoy Medical Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 949-233-1204 for questions relating to this notice.
Quantity in Commerce 44
Distribution Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = OAF and Original Applicant = ENVOY MEDICAL CORPORATION
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