DermaSensor recalled 343 units of its DermaSensor 10101 diagnostic device distributed to medical practices across several states. The device may not meet specifications, producing incorrect results or delaying referrals for patients with suspicious skin lesions. Health care providers should stop using the device immediately and contact Dermasensor Inc for instructions.
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact DERMASENSOR INC or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The DermaSensor 10101 is a software-aided diagnostic device used by physicians to assist in evaluating lesions suspicious for skin cancer.
If the device does not meet specifications, it can produce incorrect results or delay referrals, potentially affecting patient outcomes.
This recall is not described as part of a broader industry pattern in the provided information.
Clinicians may need to re-evaluate prior assessments and consider independent testing or follow-up with alternative diagnostic methods.
Identifiers appear on device labeling, user manual, or packaging. The recall page provides official details.
Not specified in the recall. Manufacturers typically outline next steps and timelines in recall communications.
Maintain records of recall notices, communications with the manufacturer, and any corrective actions taken for patients and facilities.
Model numbers: 10101. UDI-DI: 085001778610101A9. Serial Numbers: 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03. Quantity recalled: 343 units. 9 units affected. Distribution: US to MD, FL, AZ, MS, PA, NY, CT, CA. Recall date: 2025-10-13. Status: ACTIVE.
No injuries or incidents have been reported.
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