GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 20

FDA device recall Z-0195-2009 · posted 2008-11-12 · Terminated

Recall details

Recalling firm

Cardinal Health, Inc

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

EWO

Quantity affected

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.

Date initiated

2008-09-16

Date posted

2008-11-12

Date terminated

2012-05-01

Location

Madison, WI

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