Events

Recall of Device Recall REGIUS IM, RIM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Konica Minolta Medical Imaging USA, 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
    34785
  • Event Risk Class
    Class 2
  • Event Number
    Z-0862-06
  • Event Initiated Date
    2006-02-06
  • Event Date Posted
    2006-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44641
  • 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, Image Processing, Radiological - Product Code LLZ
  • Reason
    If the patient demographic data is entered into the cs-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as birthday, sex, name or patient comments, etc, the rim will populate the fields where no data has been entered with data from the previous patient.
  • Action
    The firm phoned the customers on 2/6/2006 to inform them of the recall and the corrective action associated to the recall. This will be followed up with a fax, e-mail and letter. The final step will be visiting the location to install the correct software.

Device

Device Recall REGIUS IM, RIM
  • Model / Serial
    58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
  • Product Description
    REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction.
  • Manufacturer
    Konica Minolta Medical Imaging USA, Inc.

Manufacturer

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