Class 2 Device Recall MelaFind

• Date Initiated by Firm: April 02, 2015
• Date Posted: May 20, 2015
• Recall Status: Terminated on May 04, 2016
• Recall Number: Z-1636-2015
• Recall Event ID: 71127
• PMA Number: P090012
• Product Classification: Optical diagnostic device for melanoma detection - Product Code OYD
• Product: MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
• Code Information: UDI *+M709MF100US0/$$+7DN0123MAS*
• Recalling Firm/ Manufacturer: MELA Sciences, Inc.; 50 S Buckhout St Ste 1; Irvington NY 10533-2204
• For Additional Information Contact: Mark B. Szober; 914-373-6926 Ext. 721
• Manufacturer Reason for Recall: The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
• FDA Determined Cause: Software design
• Action: The probability and histogram data within the Melafind's device displayed user interface is not included in the PMA supplement
• Quantity in Commerce: 65 units
• Distribution: AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = OYD