Device Recall Prosound F75 or F75

  • Model / Serial
    Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to PA, TX, FL, AZ, IN, OH
  • Product 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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hitachi Aloka Medical, Ltd., 10 Fairfield Blvd, Wallingford CT 06492-5903
  • Manufacturer Parent Company (2017)
  • Source
    USFDA