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

Hazard

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

Details from the source

Reason for recall: Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients. Distribution: US distribution to MD, FL, AZ, MS, PA, NY, CT, CA. Quantity: 343 (9 units affected) Lot/code info: Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.