Events

Recall of Device Recall RadiForce RX850

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eizo Corporation.

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
    71628
  • Event Risk Class
    Class 2
  • Event Number
    Z-2089-2015
  • Event Initiated Date
    2015-07-07
  • Event Date Posted
    2015-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138428
  • 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
    Display, diagnostic radiology - Product Code PGY
  • Reason
    Eizo is recalling the radiforce lcd monitors could display abnormally while connecting to particular graphics boards with displayport.
  • Action
    EIZO sent An Urgent Field Safety Notice dated July 7, 2015, to all customers who purchased the RadiForce RX440, RX650, RX850 and GX540. The notice informs customers that the RadiForce monitors could display abornormally in 6-bit (64 gradations) instead of normal 8-bit (256 gradations) or 10-bit (1024 gradations) while connecting to particular graphics boards with DisplayPort. The notice provides the customers with the actions to be taken and contact information (1-800-800-5202, M-F, 8am-4pm, PST, us.feedback@eizo.com, 5710 Warland Drive, Cypress, CA 90630).

Device

Device Recall RadiForce RX850
  • Model / Serial
    220045044, 20050044
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ.
  • Product Description
    RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. || This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.
  • Manufacturer
    Eizo Corporation

Manufacturer

Eizo Corporation
  • Manufacturer Address
    Eizo Corporation, 153, Shimokashiwano, Hakusanshi Japan
  • Manufacturer Parent Company (2017)
    Eizo Corporation
  • Source
    USFDA