MELA Sciences, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1636-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 2, 2015

Date Posted: May 27, 2015

Recall Number: Z-1636-2015

Event ID: 71127

Reason for Recall:

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

Status: Terminated

Product Quantity: 65 units

Code Information:

UDI *+M709MF100US0/$$+7DN0123MAS*

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated