Z-1636-2015Class II

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

Name: Z-1636-2015 MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection
Creator: MELA Sciences, Inc.
Published: 2015-04-02
License: https://open.fda.gov/license/

Strata Skin Sciences, Inc. / initiated 2015-04-02 / Terminated / root cause: software

FDA source

MELA Sciences, Inc. began a recall of MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection on 2015-04-02. FDA classified it as Class II and gives the reason as "The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1636-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-02
Posted: 2015-05-20
Terminated: 2016-05-04
Recalling firm: Strata Skin Sciences, Inc.
Product: MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Product code: OYD 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).
Root cause tag: software
FDA root 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
Product codes and lots: UDI *+M709MF100US0/$$+7DN0123MAS*

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1636-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1636-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-20

Product code OYD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)