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 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
    36109
  • Event Risk Class
    Class 3
  • Event Number
    Z-1481-06
  • Event Initiated Date
    2006-07-14
  • Event Date Posted
    2006-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48024
  • 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
    radiography machine - Product Code MQB
  • Reason
    A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. when the hand grip moved down, the patient who was holding it lost his or her balance and almost fell. this problem only occurred in japan with one system.
  • Action
    Konica Minolta USA contacted the site of the sole US user by phone on 7/14/06, followed by e-mail and certified mail/return receipt.

Device

Device Recall Regius

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