DermaSensor 10101Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00850017786004), received between Dec 29, 2025 and Feb 9, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298721 ↗
• MalfunctionFeb 2, 2026Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239823 ↗
• MalfunctionJan 27, 2026Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196388 ↗
• MalfunctionJan 27, 2026Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196308 ↗
• MalfunctionJan 27, 2026Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196236 ↗
• MalfunctionJan 27, 2026Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196069 ↗
• MalfunctionJan 27, 2026Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24195965 ↗
• MalfunctionJan 27, 2026Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24195841 ↗
• MalfunctionJan 27, 2026Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR DEVICE S/N (B)(6) WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194358 ↗
• MalfunctionDec 30, 2025Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR A DEVICE WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23929898 ↗
• MalfunctionDec 29, 2025Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Nonstandard Device; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE COMPLAINT IS FOR A DEVICE WHERE THE CORRECT, UNIQUE SPECTROMETER IDS AND THEIR ASSOCIATED COEFFICIENTS WERE NOT CORRECTLY CONFIGURED. THE INSTALLED SPECTROMETER DID NOT CORRECTLY ANALYZE THE WAVELENGTHS OF LIGHT WHICH RESULTED IN LOWER DEVICE RESULT SCORES, WHICH MAY IMPACT THE CLINICIAN'S CARE AND RESULT IN DELAY OF REFERRAL TO A DERMATOLOGIST. THERE IS NO ASSERTION OF DISCRETE PATIENT HARM. THE DEVICE IS AN ADJUNCTIVE DIAGNOSTIC DEVICE THAT IS INTENDED TO PROVIDE ADDITIONAL INFORMATION TO CLINICIANS, AIDING IN MANAGEMENT BUT NOT USED INDEPENDENTLY TO DETERMINE MANAGEMENT, DIAGNOSIS NOR THERAPY. DERMASENSOR DEVICE SHOULD BE USED IN CONJUNCTION WITH THE TOTALITY OF CLINICALLY RELEVANT INFORMATION FROM THE CLINICAL ASSESSMENT IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE, INCLUDING VISUAL ANALYSIS OF THE LESION, BY PHYSICIANS WHO ARE NOT DERMATOLOGISTS. THE DEVICE SHOULD BE USED ON LESIONS ALREADY ASSESSED AS SUSPICIOUS FOR SKIN CANCER AND NOT AS A SCREENING TOOL. THE DEVICE SHOULD NOT BE USED AS THE SOLE DIAGNOSTIC CRITERION NOR TO CONFIRM CLINICAL DIAGNOSIS OF SKIN CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918516 ↗