Events

Recall of Device Recall Olympus ImageManager Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus America 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
    27169
  • Event Risk Class
    Class 2
  • Event Number
    Z-0047-04
  • Event Initiated Date
    2003-08-19
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29343
  • 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
    Device, Digital Image Storage, Radiological - Product Code LMB
  • Reason
    Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.
  • Action
    OAI sent "Urgent-Device Correction" letters, dated 8/19/03, to the end users, explaining the software malfunction. The letter also provided specific instructions to the end users until the software fix is installed. For technical assistance, users can contact OAI's Technical Assistance Center 1-800-848-9024. Accompanying the letter is a questionnaire to be completed by the end users & returned to OAI for scheduling an appointment to visit the facility to install the software fix.

Device

Device Recall Olympus ImageManager Software
  • Model / Serial
    Versions 6.0 through 6.4.1 (excluding version 6.3.8)
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
  • Product Description
    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) || Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • Manufacturer Address
    Olympus America Inc., Two Corporate Center Drive, Melville NY 11747
  • Source
    USFDA