Home / Recalls / MELA Sciences, Inc. / Z-1636-2015

Z-1636-2015 Class II Terminated

Recalled by MELA Sciences, Inc. — Irvington, NY

Recall Details

Product Type
Devices
Report Date
May 27, 2015
Initiation Date
April 2, 2015
Termination Date
May 4, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
65 units

Product Description

MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.

Reason for Recall

The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).

Distribution Pattern

AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA

Code Information

UDI *+M709MF100US0/$$+7DN0123MAS*