Events

Recall of Olympus Mobile Workstations

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
    60285
  • Event Risk Class
    Class 2
  • Event Number
    Z-1160-2012
  • Event Initiated Date
    2011-10-28
  • Event Date Posted
    2012-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104945
  • 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
    Accessories, photographic, for endoscope (exclude light sources) - Product Code FEM
  • Reason
    Replacement wheels may break off from the base of the cart.
  • Action
    OLYMPUS sent an Urgent - Device Correction letter dated October 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. OLYMPUS required customers indicate on the attached questionnaire the contact information for their facility so that they can schedule a convenient time for an Olympus Field Service Representative to visit. Service personnel would inspect, and replace, as necessary any user installed casters on the WM-P1 cart. For questions regarding this recall call (483) 896-5688.

Device

Olympus Mobile Workstations
  • Model / Serial
    Models WM-DP1, WM-NP1 and WM-WP1 units with replacements wheels/castors
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, CA, NY and WV.
  • Product Description
    Olympus Mobile Workstations (Endoscopy Carts), Models WM-DP1, WM-NP1 and WM-WP1 || The mobile workstations are intended for use in medical facilities under the direction of a trained physician, and has been designed to be used with a range of Olympus equipment to facilitate GI endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • Manufacturer Address
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA