| Class 2 Device Recall MelaFind | |
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
|
|
|
|