Events

Recall of Device Recall Olympus ImageManager

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
    26637
  • Event Risk Class
    Class 3
  • Event Number
    Z-1126-03
  • Event Initiated Date
    2003-03-05
  • Event Date Posted
    2003-08-12
  • 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=28041
  • 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 defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.
  • Action
    Olympus America, Inc. sent "Urgent-Device Correction" letters, dated 3/5/03, to the medical facilities, advising them of the software malfunction. The letter provides instructions to health care practitioners and that a new software release is being developed to prevent a recurrence.

Device

Device Recall Olympus ImageManager
  • Model / Serial
    Versions 6.0 through 6.4
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Medical facilities nationwide and Puerto Rico; and 4 foreign accounts in Canada, Ecuador, Chile & Mexico.
  • Product Description
    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4 --- Common name: Medical image storage device. Class I, 510 (k) exempt.
  • Manufacturer
    Olympus America Inc.

Manufacturer

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