FDA Medical Device Recalls (openFDA)
DERMASENSOR INC: DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
- Recall number
- Z-0583-2026
- Recalling firm
- DERMASENSOR INC
- Product
- DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
- Status
- Open, Classified
- Initiated
- 2025-10-13
- Posted
- 2025-11-21
- Terminated
- not on file
- Reason
- Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
- Root cause
- Process control
- Action
- DermaSensor began notification of consignees on about 10/13/2025 via telephone call with a follow up letter. The telephone call notified consignees of the issue and confirmed if the affected units were or were not on hand. The letter then sent to the consignees again advised them of the issue and instructed them to examine inventory for affected units, to complete and return the Customer Notification Response Form, and arrange a visit with DermaSensor for the device correction. Once the affected unit is examined, DermaSensor can determine if the device contains the component issue and if it does, DermaSensor will provide the consignee with the dates the scans were taken and the correct results. If the consignee's device does not contain the component issue, no further actions need to be taken.
- Quantity
- 343 (9 units affected)
- Distribution
- US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
- Lot, serial or model codes
- Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QZS
- Firm FEI
- 3017254114
- Firm city
- Miami
- Firm state
- FL
- 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