BEUDAMED
    FDA Recall Terminated

    Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.

    Recall: Z-1282-2021 · Initiated March 1, 2021

    Recall

    Recall Number
    Z-1282-2021
    Event Number
    87493
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 1, 2021
    Terminated
    November 4, 2021
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.

    Reason

    Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.

    Action

    On 3/1/2021, Hitachi issued an Urgent Medical Device Correction notice to customers for the Arietta 850 system operating with software version 4.0.2 that utilizes SWE function with the C252 probe. The R&D department of Hitachi Ltd. (Manufacturer) has identified an error in the focus point and transducer aperture settings in the SWE function at the manufacturer facility. This error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    1