Events

Recall of MelaFind

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

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
    71127
  • Event Risk Class
    Class 2
  • Event Number
    Z-1636-2015
  • Event Initiated Date
    2015-04-02
  • Event Date Posted
    2015-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136172
  • 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
    Optical diagnostic device for melanoma detection - Product Code OYD
  • Reason
    The probability and histogram data within the melafind's device displayed user interface lacks approval (not included in the pma supplement).
  • Action
    The probability and histogram data within the Melafind's device displayed user interface is not included in the PMA supplement

Device

MelaFind
  • Model / Serial
    UDI *+M709MF100US0/$$+7DN0123MAS*
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
  • Product Description
    MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
  • Manufacturer
    MELA Sciences, Inc.

Manufacturer

MELA Sciences, Inc.
  • Manufacturer Address
    MELA Sciences, Inc., 50 S Buckhout St Ste 1, Irvington NY 10533-2204
  • Manufacturer Parent Company (2017)
    MELA Sciences, Inc.
  • Source
    USFDA