BEUDAMED
    FDA Recall Terminated

    Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications

    Recall: Z-1696-2017 · Initiated June 11, 2014

    Recall

    Recall Number
    Z-1696-2017
    Event Number
    76763
    Firm
    Hitachi Aloka Medical, Ltd.
    FEI Number
    1000120865
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 11, 2014
    Terminated
    July 3, 2017
    Address
    10 Fairfield Blvd, Wallingford, CT, 06492-5903

    Description

    Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications

    Reason

    Loosened monitor arm.

    Action

    Hitachi Loki Medical sent a customer letter dated June 11, 2014, to affected consignees. The letter informed consignees of the issue and actions the firm planned to take. For questions regarding this recall call 888-782-5652.

    Distribution

    Nationwide Distribution to PA, TX, FL, AZ, IN, OH