Events

Recall of ECLOS Computed Tomography XRay System

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

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
    52430
  • Event Risk Class
    Class 2
  • Event Number
    Z-1652-2009
  • Event Initiated Date
    2009-04-14
  • Event Date Posted
    2009-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82973
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Reason
    Incorrect scale on image: a software error can occur if two (2) different field-of-view (fov) settings are registered in a protocol using multi-reconstruction. this could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.
  • Action
    HMSA issued an URGENT - DEVICE CORRECTION notification to their customers on 4/14/2009. The notification describes the potential software error and the condition under which these image distortions can occur. The notification goes on to provide the customer with a work-around procedure which they can use to avoid encountering this issue with their current software configuration(s). The letter states that the firm will be installing updated software on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting each customer and making arrangements to come out and install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, which the customer can use to obtain additional information, if desired.

Device

ECLOS Computed Tomography XRay System
  • Model / Serial
    The recalled ECLOS system units are identified with the following Code Numbers: E1014, E5003 through E5005
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution, including Puerto Rico (PR).
  • Product Description
    Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less.
  • Manufacturer
    Hitachi Medical Systems America Inc

Manufacturer

Hitachi Medical Systems America Inc
  • Manufacturer Address
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • Manufacturer Parent Company (2017)
    Hitachi Ltd
  • Source
    USFDA