Events

Recall of Device Recall Ellex Motorised Safety Filter

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
    54019
  • Event Risk Class
    Class 2
  • Event Number
    Z-0578-2010
  • Event Initiated Date
    2009-02-11
  • Event Date Posted
    2010-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87210
  • 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
    Potential for two screws important in the design of the safety filter to come loose.
  • Action
    Ellex issued a bulletin stating the problem and identifying the affected products. Customers are to remove the Motorised Safety Filter from clinical use if the green laser light is visible while viewing through the microscope at any time during use of the Solitaire laser. The Bulletin also states that customers should contact an Ellex approved Service Engineer to investigate and perform the Field Corrective Action listed. The manufacturer will remedy the defect or bring the product into compliance free of charge. Ellex will inspect and rework all affected safety filters sold prior to February 2009.

Device

Device Recall Ellex Motorised Safety Filter
  • Model / Serial
    Solitaire LP4532 photocoagulator.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Motorised Safety Filter, Wild; Model number 6339590. || Intended for photocoagulation.
  • 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