Z-0583-2026Class II

DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic...

Name: Z-0583-2026 DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic...
Creator: Dermasensor Inc
Published: 2025-10-13
License: https://open.fda.gov/license/

Dermasensor Inc / initiated 2025-10-13 / Open, Classified / root cause: manufacturing process

FDA source

DERMASENSOR INC began a recall of DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for... on 2025-10-13. FDA classified it as Class II and gives the reason as "Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0583-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-13
Posted: 2025-11-21
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
Product code: QZS Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
Reason for recall: Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Root cause tag: manufacturing process
FDA 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 in commerce: 343 (9 units affected)
Distribution: US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Product codes and lots: Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0583-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0583-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-21

Product code QZS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)