Company: Viasys Healthcare, Inc/Cardinal Health Inc.
Date of Enforcement Report 12/10/2008
Class:lll
PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor version 6.0.1 Distributed with 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, Recall # Z-0195-2009
REASON
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 mode, and switching data acquisition from right ear to the left ear, if the audiologist clicks back on the right ear to annotate or mark it, the data acquisition from the left ear is then assigned to the record of the right ear. The waveform is labeled as a right ear response even though the left ear was stimulated and vice versa. Mislabeling of the results could lead to a decision to fit a hearing aid on the incorrect ear and result in excessive hearing aid amplification and possible damage to the misdiagnosed ear. B. VEMP Marketing Correction: The US Food and Drug Administration is requiring the removal of the Vestibular Evoked Myogenic Potential (VEMP) function from the GSI Audera products in the field until this function has been granted FDA’s clearance.
RECALLING FIRM/MANUFACTURER
Cardinal Health, Inc., Madison , WI , by letter dated September 16, 2008, September 22, and September 26, 2008, Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
297 units
DISTRIBUTION
Nationwide