Hitachi Hi Vision Preirus User Manual

Posted : admin On 01.06.2020

Hitachi Hi Vision Ascendus Manual

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Since introducing the first real-time ultrasound machine with digital scan converter in 1980, Hitachi has developed a rich technological expertise which now delivers the HI VISION Preirus – a new generation ultrasound platform with advanced ergonomic architectural design, the latest broadband beamforming technology and ultra high speed. Hitachi HI VISION Preirus Ultrasound, Diagnostic for Sale. Check out our extensive catalog of New & Used Hitachi HI VISION Preirus Ultrasound, Diagnostic devices. More than 200,000 items of Imaging devices & medical equipment.

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Hi All,

I am looking for a service manual for a Hitachi Hivision Preirus. I would be most thankful if anybody can help me.

Regards

John Williams

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Hitachi Hi Vision Ascendus Manual

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Class 2 Device Recall HIVISION Preirus, Avius ultrasound systems

Z-2467-2011
Date Initiated by Firm	April 18, 2011
Date Posted	June 08, 2011
Recall Status¹	Terminated ³ on February 19, 2013

Recall Event ID

58703

System, imaging, pulsed doppler, ultrasonic - Product CodeIYN

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 OH 44087

For Additional Information Contact

330-425-1313 Ext. 3720

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

Software design

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.

24 system units

Nationwide distribution: USA including states of: CA, MD, KY, FL, MN, NJ, IA, OH, TX, IL, and IA.

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 = IYN and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.