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U.S. Department of Health and Human Services

Class 2 Device Recall MelaFind

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  Class 2 Device Recall MelaFind see related information
Date Initiated by Firm April 02, 2015
Date Posted May 20, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = STRATA SKIN SCIENCES, INC.
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