Recall Z-1704-2010 ยท GWJ Stimulator, Auditory, Evoked Response
Intelligent Hearing Systems Corp.
Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016
| Date | May 27, 2010 (initiated Oct 21, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 50 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.