Events

Recall of Device Recall Gyrus CyberWand

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gyrus ACMI Corporation.

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
    37999
  • Event Risk Class
    Class 2
  • Event Number
    Z-1073-2007
  • Event Initiated Date
    2007-05-23
  • Event Date Posted
    2007-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52661
  • 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
    Ultrasonic Lithotripter - Product Code FFK
  • Reason
    Sterilization instructions not adequate for sterilizing.
  • Action
    Gyrus has informed their sales force to visit each customer that has a CyberWand system(s) and hand deliver a letter, dated May 23, 2007, that explains the situation and requests that the customer cease using the unit and segregate it to prevent accidental use. The letter also explains that the firm is collecting any sterilization trays with printed sterilization instructions and replacing them. The rep will assist the customer in complying. The customer will also be required to complete a reply form to track compliance.

Device

Device Recall Gyrus CyberWand
  • Model / Serial
    Product distributed prior to May 7, 2007.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Gyrus CyberWand Ultrasonic Lithotripter System includes: || CW-USLS CyberWand USL System || CW-USLT CyberWand USL Transducer || CW-USLRBP CyberWand USL Renal/Bladder Probe Set || CW-USLTT CyberWand USL Transducer Sterilization Tray
  • Manufacturer
    Gyrus ACMI Corporation

Manufacturer

Gyrus ACMI Corporation
  • Manufacturer Address
    Gyrus ACMI Corporation, 136 Turnpike Road, Southborough MA 01772-2118
  • Source
    USFDA