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U.S. Department of Health and Human Services

Class 2 Device Recall GSI AUDERA

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  Class 2 Device Recall GSI AUDERA see related information
Date Initiated by Firm September 16, 2008
Date Posted November 12, 2008
Recall Status1 Terminated 3 on May 01, 2012
Recall Number Z-0195-2009
Recall Event ID 49546
510(K)Number K011135  
Product Classification Audiometer - Product Code EWO
Product 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 lesions in the auditory pathway on neonates through adults.
Code Information 11/25/2008 Final List of UPDATED serial numbers: 20020100 through 20030339 (format used until the end of 2003 was yyyynnnn) and range AT040350 through AT070351 (format beginning with 2004 is ATyynnnn):   Only those units that have both 2.6 software and Auditory Evoked Potential (AEP) or Cortical Auditory Evoked Potential (CAEP) functionality were affected by the split screen issue.   S/N System (version 2.6 software)   AT040554 AT40565 AT040558 AT040560 AT040559 AT040566 AT040564 AT040570 AT040571 AT040591 AT040594 AT040596 AT040596 AT050606 AT050619 AT040599 AT050622 AT050625 AT050634 AT050639 AT050640 AT050651 AT050654 AT050655 AT050652 AT050653 AT050657 AT050663 AT050674 AT050673 AT050675 AT050682 AT050680 AT050683 AT050708 AT050692 AT050690 AT050706 AT050707 AT050710 AT050732 AT050691 AT050752 AT050755 AT050743/AT050748 AT050765 AT050778 AT050776 AT050782 AT050784 AT050795 AT050801 AT050797 AT050799 AT050786 AT050805 AT050809 AT050812 AT050806 AT050816 AT050819 AT050818 AT050820 AT050829 AT050834 AT050836 AT050836 AT050842 AT050852 AT050843 AT050855 AT050853 AT060859 AT060892 AT060862 AT060864 AT060868 AT060882 AT060885 AT060886 AT060883 AT060891 AT060894 AT060884 AT060903 AT060904 AT050691P AT060914 AT060911 AT060912 AT060913 AT060892 AT060925 AT060937 AT060926 AT060940 AT060941 AT060942 AT060938 AT060944 AT060945 AT060946 AT060949 AT070205 AT070206 AT070207 AT060938 AT070219 AT070218 AT070226 AT070227 AT070228 AT070230 AT070241 AT070200 AT070253 AF071624 AT070252 AT070257 AT070221 AT070220 AT070269 AT070272 AT070273 AT070274 AT070278 AT070280 AT070290 AT070292 AT070289 AT070299 AT070304 AT070310 AT070307 AT070314 AT070317 AT070333 AT070306 AT070331 AT070339 AT070340 AT070341 AT070350 AT070370 AT070352 AT070257 AT070369 AT070376 AT070360 AT070396 AT080399 20030241 20030338 AT080417 AT070339 AT070318 AT080418 AT080426 and AT080427.  Additional serial numbers to be supplied later.                                                                                                        
Recalling Firm/
Manufacturer		 Cardinal Health, Inc
5225 Verona Rd
Madison WI 53711-4497
For Additional Information Contact
608-441-5000
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 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 capability. "Attachment A-Verification Form" must be completed by the recipient/distributor. If you need assistance in making the software revision determination or have further questions, please contact the Cardinal Health (formerly VIASYS) Neurocare/GSI Technical Support Group at 1-800-356-0007, 1-800-700-2282, 608-273-5000, or by e-mail at gsiservice@viasyshc.com or gsiservice@cardinalhealth.com.
Quantity in Commerce 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.
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.
510(K) Database 510(K)s with Product Code = EWO and Original Applicant = NICOLET BIOMEDICAL
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