FDA Medical Device Recalls (openFDA)
MELA Sciences, Inc.: MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
- Recall number
- Z-1636-2015
- Recalling firm
- MELA Sciences, Inc.
- Product
- MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
- Status
- Terminated
- Initiated
- 2015-04-02
- Posted
- 2015-05-20
- Terminated
- 2016-05-04
- Reason
- The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
- 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
- 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
- Lot, serial or model codes
- UDI *+M709MF100US0/$$+7DN0123MAS*
- 510(k) numbers
- not on file
- PMA numbers
- ["P090012"]
- Product code
- OYD
- Firm FEI
- 3002942014
- Firm city
- Irvington
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28