Recall Z-1636-2015— MELA Sciences, Inc.

Name: FDA recall Z-1636-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-02

Class II · Terminated

Class II FDA medical device recall by MELA Sciences, Inc., initiated 2015-04-02, terminated 2016-05-04. FDA's recall record names no specific 510(k) clearance for this event. Product: MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.. Reason: The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement)..

Recalling firm: MELA Sciences, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-02
Terminated: 2016-05-04
Firm location: Irvington, NY, United States

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.