Recall Z-0195-2009 ยท EWO Audiometer
Cardinal Health, Inc
GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds by evoking auditory brainstem or steady state brainstem response and to aid in detection of
| Date | Nov 12, 2008 (initiated Sep 16, 2008) |
| Status | Terminated |
| Reason | GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Correction: GSI Audera units with version 2.6 software may mislabel Auditory Evoked Potential (AEP) waveform responses with respect to the identification of the stimulus ear. When using 2.6 software in split-screen mod |
| Root cause | Software design |
| Action | Consignees were sent a Cardinal Health "Urgent: Medical Device Correction" letter dated September 16, 2008 on 9/22/08 and 9/26/08. The letter was addressed to the Customer/Distributor. The letter instructed consignees to perform installations if they have the following software: 1) For Version 2.6 software, you must install Version 2.6.5 software to correct a Split- Screen performance issue and to remove the VEMP function. 2) For Version 2.0 or 2.1 software, you must install the Protocol Update Software to remove the VEMP function. Versions 2.0 and 2.1 do not contain Split-Screen capabili |
| Quantity | 297 |
| Distribution | Nationwide including states of AL AZ CA CO CT DC FL GA HI IA IA IL IN KS LA MA MD ME MN MO MS NC NC NH NJ NM NY OH OK PA RI SC TN TX UT VA WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011135 | GSI AUDERA Nicolet Biomedical, Jul 26, 2001 |