Events

Recall of Olympus Single Use Mechanical Lithotriptor

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
    44929
  • Event Risk Class
    Class 3
  • Event Number
    Z-0105-2008
  • Event Initiated Date
    2007-09-20
  • Event Date Posted
    2007-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64539
  • 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
    Single Use Mechanical Lithotriptor - Product Code LQC
  • Reason
    Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath.
  • Action
    The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.

Device

Olympus Single Use Mechanical Lithotriptor
  • Model / Serial
    Model number BML-V232QR-26: Lot numbers 75K, 76K, and 77K.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America, Inc.
  • 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