DERMASENSOR INC recalls DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided ad…

Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0583-2026
• FDA device classification · QZSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.1830The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find DERMASENSOR INCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.