Z-1636-2015 Class II Terminated
FDA device recall Z-1636-2015 was initiated by MELA Sciences, Inc. on April 2, 2015 and is designated Class II. Reason for recall: The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement). The recall status is terminated (terminated May 4, 2016). Affected quantity: 65 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2015
- Initiation Date
- April 2, 2015
- Termination Date
- May 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 units
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).
Distribution Pattern
AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
Code Information
UDI *+M709MF100US0/$$+7DN0123MAS*