Events

Recall of Konica Minolta PrintLink III

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
    36658
  • Event Risk Class
    Class 2
  • Event Number
    Z-0220-2007
  • Event Initiated Date
    2006-10-06
  • Event Date Posted
    2006-11-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49109
  • 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
    Medical Imaging Communication Device - Product Code LMD
  • Reason
    The power supply of a unit located in japan overheated and caused a smoke condition and a small amount of flame coming off the unit.
  • Action
    Letters were sent to all customers by first class US mail, certified receipt requested on 10/10/2006. Customers were also notified by fax and e-mail and a phone call on the same day.

Device

Konica Minolta PrintLink III
  • Model / Serial
    Product code 0770, serial numbers: 0002, 0003, 0011, 0012, 0013, 0014, 0015, 0020, 0021, 0022, 0023, 0024, 0035, 0036, 0037, 0038, 0081, 0082, 0083, 0084, 0085, 0124, 0125, 0126, 0147, 0148, 0149, 0156, 0157, 0158, 0159, 0160.   Product code 0771, serial numbers: 0001, 0003, 0004, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0026, 0027, 0028, 0029, 0030, 0034, 0035, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0065, 0066, 0067, 0068, 0069, 0125, 0126, 0127, 0128, 0129, 0155, 0156, 0157, 0159, 0160, 0161, 0162, 0163, 0167, 0168, 0169, 0170, 0234, 0235, 0236, 0241, 0242, 0243, 0244, 0245.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide to imaging centers, hospitals and clinics.
  • Product Description
    Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device || Model IV - product code 5000230 || Model ID, product code 5000330 || Konica Minolta Medical & Graphic, Inc. || No. 26-2, Nishishinjuku 1-chrome, Shinjuku-ku, Tokoyo 163-0512, Japan
  • 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