Events

Recall of Konica Minolta

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
    27488
  • Event Risk Class
    Class 3
  • Event Number
    Z-0150-04
  • Event Initiated Date
    2003-10-09
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29950
  • 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
    Film, Radiographic - Product Code IWZ
  • Reason
    Loss of detail at density of 1.00 to 2.00, on certain bony structures found in original clinical films.
  • Action
    Recall letter sent out to direct accounts on 10/9/2003. The consignees are to review boxes and cases of emulsion film and contact the firm for a return aurthorization number.

Device

Konica Minolta
  • Model / Serial
    Emulsion''s numbers( X=any number): X742, X842, X152, and X023.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The firm distributed the duplicating firm to 960 imaging locations, clinics, and hospitals nationwide. There are 5 VA medical centers located in VA, RI, WI, NH, and TN.
  • Product Description
    Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842, X152. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only and Emulsion Number X152. SR-DUP C 14x17 Emulsion X023 only.
  • 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