Events

Recall of Device Recall Olympus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integrated Medical Systems 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
    73088
  • Event Risk Class
    Class 2
  • Event Number
    Z-0909-2016
  • Event Initiated Date
    2016-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143143
  • 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
    Endoscope, flexible - Product Code GCQ
  • Reason
    If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
  • Action
    The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.

Device

Device Recall Olympus
  • Model / Serial
    Serial Numbers: 2913081,2600279
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and in Australia.
  • Product Description
    Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
  • Manufacturer
    Integrated Medical Systems Inc

Manufacturer

Integrated Medical Systems Inc
  • Manufacturer Address
    Integrated Medical Systems Inc, 3200 2nd Ave N, Birmingham AL 35222-1212
  • Manufacturer Parent Company (2017)
    Integrated Medical Systems Inc.
  • Source
    USFDA