Recall Z-0583-2026 ยท QZS Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
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
| Date | Nov 21, 2025 (initiated Oct 13, 2025) |
| Status | Open, Classified |
| 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 d |
| Quantity | 343 (9 units affected) |
| Distribution | US distribution to MD, FL, AZ, MS, PA, NY, CT, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.