CLARITY II COMPL_BODY_AIRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08809447652610), received between Feb 7, 2025 and Feb 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Electrical /Electronic Property Problem; Unexpected/Unintended Radiation Output; Electrical /Electronic Property Problem; Unexpected/Unintended Radiation Output

  SITE REPORTED CLARITY II'S FOOT PEDAL IS FIRING UNINTENTIONALLY AND "THE ONLY WAY THEY CAN STOP IT IS TO TURN THE MACHINE OFF." NO INJURIES WERE REPORTED. CYNOSURE FIELD SERVICE ENGINEER (FSE) ARRIVED AT SITE AND EVALUATED THE DEVICE. FSE WAS ABLE TO DUPLICATE THE CONTINUOUS MISFIRING. FSE STATES, "THE UNIT HAS OUT OF DATE FIRMWARE AND DOES NOT HAVE A FERRITE COIL OR GROUNDED HANDPIECE ASSEMBLY." TO RESOLVE THE REPORTED ISSUE, FSE REPLACED THE HANDPIECE WITH PROPER GROUND VERSION, ADDED A FERRITE COIL AND PERFORMED THE NECESSARY FIRMWARE UPDATES. THIS EVENT IS REPORTABLE SINCE THIS IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) DUE TO DEVICE FIRING UNINTENTIONALLY ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334192 ↗
• MalfunctionFeb 7, 2025Electrical /Electronic Property Problem; Unexpected/Unintended Radiation Output; Electrical /Electronic Property Problem; Unexpected/Unintended Radiation Output

  THE CUSTOMER REPORTED THAT WHEN USING CLARITY II DEVICE FOOT PEDAL, THE DEVICE BEGAN FIRING CONTINUOUSLY FROM THE HAND PIECE. THE DEVICE HAD TO BE SHUT DOWN TO STOP THE HAND PIECE FROM FIRING. IT WAS REPORTED THAT THERE WERE NO INJURIES THAT OCCURRED DURING THIS INCIDENT. THERE WAS NO INJURY REPORTED ASSOCIATED WITH THIS INCIDENT. THE CLINICAL TEAM MADE MULTIPLE CONTACT ATTEMPTS TO OBTAIN ADDITIONAL INFO ABOUT THE REPORTED EVENT, INCLUDING PATIENT DETAILS AS WELL AS TREATMENT AND PARAMETER DETAILS, HOWEVER, THESE INFORMATION REQUESTS WENT UNANSWERED. A TRAINED FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE FOR EVALUATION. DURING THIS TIME THE REPORTED ISSUE OF CONTINUOUS FIRING WAS DUPLICATED. TO CORRECT THIS ISSUE, THE DEVICE FIRMWARE WAS UPDATED AND THE HAND PIECE HAD THE FERRITE GROUNDING COIL INSTALLED. THE FIELD SERVICE ENGINEER RECOMMENDED THE CUSTOMER REPLACE THIS HAND PIECE WITH AN UPDATED AND GROUND HAND PIECE VERSION. WHEN THE REPAIRS WERE COMPLETE, THE DEVICE WAS TESTED AND PASSED ALL ENERGY AND FUNCTIONAL TESTS AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333929 ↗