FDA Device recall Z-1636-2015
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection
- FDA Device
- Class II
- terminated
- Published 2015-05-27
On 2015-05-27 the FDA classified a Class II recall of MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection by Mela Sciences, citing the probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1636-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-02 |
| Published | 2015-05-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mela Sciences |
| Distribution | AL, CA, CO, CT, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA |
Product
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Reason
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
Identifiers
| code_info | UDI *+M709MF100US0/$$+7DN0123MAS* |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1636-2015%22
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