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U.S. Department of Health and Human Services

Class 2 Device Recall SmartEP

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  Class 2 Device Recall SmartEP see related information
Date Initiated by Firm October 21, 2008
Date Posted May 27, 2010
Recall Status1 Terminated 3 on September 21, 2011
Recall Number Z-1704-2010
Recall Event ID 54168
Product Classification neurological hearing tester - Product Code GWJ
Product Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016
Code Information IHS2195, IHS3048V, IHS3116, IHS3128V, IHS3182, IHS3420, IHS3431, IHS3443, IHS3485, IHS3545, IHS3563, IHS3565, IHS3580, IHS3591, IHS3642, IHS3665, IHS3668, IHS3683, IHS3829, IHS3878, IHS3967, IHS4001, IHS2209, IHS2281, IHS3110, IHS3324, IHS3410, IHS3426, IHS3460, IHS3542, IHS3548, IHS3623, IHS3638, IHS3787, IHS3961, IHS3011, IHS3387, IHS3429, IHS3432, IHS3494, IHS3593, IHS3619, IHS3704, IHS2184, IHS3008, IHS3248, IHS3314, IHS3819, IHS3893, IHS4040.  
Recalling Firm/
Manufacturer		 Intelligent Hearing Systems Corp.
6860 Sw 81st St
Miami FL 33143-7708
For Additional Information Contact Edward Miskiel, Ph.D.
305-668-6102 Ext. 11
Manufacturer Reason
for Recall		 This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification application must be submitted and cleared in order to market and sell devices with Vestibular Evoked Myogenic Potential (VEMP) specific functions. The Food and Drug Administration considers that the VEMP testing functions
FDA Determined
Cause 2		 Device Design
Action Intelligent Hearing Systems sent a letter "Information Regarding the Discontinued Use of the SmartEP Evoked Response System for Vestibular Evoked Myogenic Potentials (VEMP) Testing" dated September 30, 2008 to customers and distributors. Each customer will receive an upgrade and VEMP removal kit which will remove the VEMP feature.
Quantity in Commerce 50
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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