Events

Recall of Device Recall Ellex Ultra Q

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ellex Medical Pty Ltd.

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
    58076
  • Event Risk Class
    Class 2
  • Event Number
    Z-1841-2011
  • Event Initiated Date
    2011-02-15
  • Event Date Posted
    2011-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98267
  • 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
    ophthalmic laser - Product Code HQF
  • Reason
    Unintended laser emission while the user was moving the joystick for targeting.
  • Action
    Ellex notified all distributors that have received the affected devices per Global Customer Service Bulletin GSB-11 -01a, dated 25 February 2011.

Device

Device Recall Ellex Ultra Q
  • Model / Serial
    Units manufactured between August 2007 and 20 February 2011.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    worldwide distribution
  • Product Description
    Ellex Ultra Q LQP3106-U ophthalmic laser
  • Manufacturer
    Ellex Medical Pty Ltd

Manufacturer

Ellex Medical Pty Ltd
  • Manufacturer Address
    Ellex Medical Pty Ltd, 82 Gilbert Street, Adelaide Australia
  • Manufacturer Parent Company (2017)
    Ellex Medical Lasers Ltd.
  • Source
    USFDA