Recall Z-2467-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Hitachi Medical Systems America Inc
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 v
| Date | Jun 8, 2011 (initiated Apr 18, 2011) |
| Status | Terminated |
| 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 lead |
| Root cause | 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 Helpl |
| Quantity | 24 system units |
| Distribution | Nationwide distribution: USA including states of: CA, MD, KY, FL, MN, NJ, IA, OH, TX, IL, and IA. |
| FDA record | Open on fda.gov |