Events

Recall of Device Recall Regius

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Konica Medical Imaging, 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
    32068
  • Event Risk Class
    Class 3
  • Event Number
    Z-1391-05
  • Event Initiated Date
    2005-03-30
  • Event Date Posted
    2005-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39071
  • 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
    Digitizer, Image, Radiological - Product Code LMA
  • Reason
    One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.
  • Action
    The firm contacted all customers of the problem on 4/7/2005.

Device

Device Recall Regius
  • Model / Serial
    All serial numbers.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    These units have been distributed to hospitals and clinics nationwide.
  • Product Description
    Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
  • Manufacturer
    Konica Medical Imaging, Inc.

Manufacturer

Konica Medical Imaging, Inc.
  • Manufacturer Address
    Konica Medical Imaging, Inc., 411 Newark Pompton Tpke, Wayne NJ 07470-6657
  • Source
    USFDA