Events

Recall of Device Recall Ellex Solitarie Opthalmic Laser System

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

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
    45499
  • Event Risk Class
    Class 2
  • Event Number
    Z-0286-2008
  • Event Initiated Date
    2007-06-13
  • Event Date Posted
    2007-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65655
  • 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
    Electric shock from power supply : the power supply has a defect which can cause an electrical shock to user.
  • Action
    Ellex, Inc. called each customer on 6/13/07, about the problem (defect which can cause electric shock) and advised that they would be performing modification of the power supply in the laser system and scheduling a field service visit to complete the work. Upon completion of the modification, the service technician completed the service record and left a copy with each client and informed them of the completed work. A copy of each completed service record was sent to Ellex Medical Pty. Ltd. On 9/27/07, Ellex sent a letter to all consignees, informing them that all modifications by service technicians' have been completed, and that their Solitaire LP4532 laser and/or Intregre Duo LP1RG is up to the manufacturers specifications and is in good operating order.

Device

Device Recall Ellex Solitarie Opthalmic Laser System
  • Model / Serial
    Solitaire-DGS P/N 303896 (serial # /system #): 31577 /4A2149, 32263 /4A2150, 32256 /4A2152, 32224 /4A2162, 32264 /4A2165, 32627 /4A2174D   Solitarie-SGS P/N 3038960 serial # /system #): 31313 /4A2129, 32223 /4A2148, 32728 /4A2160, 32733 /4A2175S
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including states of WI, PA, CO, CA, NC, NY, SC, MD, and MS, and countries of Canada and Brazil.
  • Product Description
    Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.
  • Manufacturer
    Ellex USA

Manufacturer

Ellex USA
  • Manufacturer Address
    Ellex USA, 7138 Shady Oak Road, Eden Prairie MN 55344
  • Source
    USFDA