Events

Recall of Device Recall Prosound F75 or F75

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hitachi Aloka Medical, Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76763
  • Event Risk Class
    Class 2
  • Event Number
    Z-1696-2017
  • Event Initiated Date
    2014-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154135
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 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.

Device

Device Recall Prosound F75 or F75
  • Model / Serial
    Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894
  • Product Classification
    Radiology Devices
  • 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
    Hitachi Aloka Medical, Ltd.

Manufacturer

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