Company: Hitachi Medical Systems America Inc.
Date of Enforcement Report 8/10/11
Class ll:
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. Recall # Z-2467-2011
REASON
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 leading to the possible patient mis-diagnosis of vessel stenosis.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter dated April 15, 2011.
Manufacturer: Hitachi Medical Corp., Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide
