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U.S. Department of Health and Human Services

Class 2 Device Recall HIVISION Preirus, Avius ultrasound systems

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 Class 2 Recall
HIVISION Preirus, Avius ultrasound systems
see related information
Date Posted June 08, 2011
Recall Status1 Terminated on February 19, 2013
Recall Number Z-2467-2011
Recall Event ID 58703
Premarket Notification
510(K) Numbers
K093466  K102901 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.
Code Information All codes manufactured from 11/2/2009 to 3/4/2011, are subject to recall. Preirus (KE10584001-KE17585003)/Avius (KE11088001-KE11476102)
Recalling Firm/
Manufacturer
Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg, Ohio 44087
Consumer Instructions For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.
Manufacturer Reason
for Recall
Software anomaly. The Doppler Trace Measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. The recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity lead
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, Hitachi, sent a "DEVICE CORRECTION NOTICE" letter dated April 15, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were inform of the nature of the software error in the Doppler Trace Measurement feature; the circumstances under which this error can occur; and the safety issue involved should incorrect values generated lead to a false diagnosis of stenosis in a patient. The letter provides the customer with a workaround solution in order to avoid this issue. The customer were also instructed to call the HMSA Applications Helpline at 877-871-2777 to reprogram their system to temporarily eliminate the noted safted issue and to immediately have all selections unchecked on the Doppler trace measurement result store setting set up screen. The notification letter also states that Hitachi Medical Systems America (HMSA) will be having their service personnel schedule a visit at each customer location and install a software upgrade on each affected system unit in order to directly address, and permanently resolve this issue. If you need any further information regarding this notice, please contact the Manager of Regulatory Affairs at 800-800-3106 x3720 or email to: thistlewaited@hitachimed.com.
Quantity in Commerce 24 system units
Distribution Nationwide distribution: USA including states of: CA, MD, KY, FL, MN, NJ, IA, OH, TX, IL, and IA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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