Events

Recall of Device Recall Ellipse Multiflex system

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

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
    74189
  • Event Risk Class
    Class 2
  • Event Number
    Z-1697-2016
  • Event Initiated Date
    2016-05-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146672
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
  • Action
    Ellipse A/S has evaluated our instructions in the Service Manual and brought those parts into the Operator's Manual as well which we believe is relevant and usable for the end-user of the product. The details in efficiently implementing the distribution of the manual has been evaluated and coordinated with our service provider in the US. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions, please call (760) 798-9550.

Device

Device Recall Ellipse Multiflex system
  • Model / Serial
    All serial numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
  • Product Description
    Ellipse ND: YAG Laser applicator for Ellipse Multiflex || Medical Laser Products.
  • Manufacturer
    Ellipse A/S

Manufacturer

Ellipse A/S
  • Manufacturer Address
    Ellipse A/S, Agern Alle 11, Horsholm Denmark
  • Manufacturer Parent Company (2017)
    Lupert Ltd
  • Source
    USFDA