ALMA HARMONY CONSOLE WITH GREEN DIODE 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07290110123369), received between Feb 13, 2025 and Jun 23, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Use of Incorrect Control/Treatment Settings

  IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM.

  Patient problems: Burn(s)

  MAUDE report 25589708 ↗
• InjuryMar 30, 2026Failure to Deliver Energy; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE IMPORTER REPORTED THAT A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE ALMAHARMONY SYSTEM.

  Patient problems: Burn(s)

  MAUDE report 24723899 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT THEIR PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING THE USE OF THE ALMA HARMONY SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION WHICH DETERMINED THAT THE BURN HAD LIKELY OCCURRED DUE TO EXCESSIVE ENERGY AND COULD RESULT IN A PERMANENT SCAR. THEREFORE, WE ARE REPORTING THIS IN GOOD FAITH. THE CLEARSKIN HANDPIECE USED WITH THE ALMA HARMONY SYSTEM DURING THE TREATMENT WAS RETRIEVED FOR INSPECTION AS PART OF THE INVESTIGATION. UPON INSPECTION THE DEVICE DID NOT MEET MANUFACTUER'S SPECIFICATION AND WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

  Patient problems: Burn(s)

  MAUDE report 24705987 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT THEIR PATIENT SUSTAINED A SUPERFICIAL SECOND-DEGREE BURN AT THE TREATMENT SITE FOLLOWING THE USE OF THE ALMA HARMONY SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION WHICH DETERMINED THE BURN WAS LIKELY DUE TO EXCESSIVE ENERGY AND COULD RESULT IN A PERMANENT SCAR. THEREFORE, WE ARE REPORTING THIS IN GOOD FAITH. THE CLEARSKIN HANDPIECE USED WITH THE ALMA HARMONY SYSTEM DURING THE TREATMENT WAS RETRIEVED FOR INSPECTION AS PART OF THE INVESTIGATION. UPON INSPECTION, THE DEVICE DID NOT MEET MANUFACTURER'S SPECIFICATIONS AND WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24700896 ↗
• InjuryMar 26, 2026Failure to Deliver Energy; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE IMPORTER REPORTED THAT A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A SUPERFICIAL SECOND DEGREE BURN AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24699879 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  THE IMPORTER REPORTED THAT A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BLISTER AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM.

  Patient problems: Burn(s)

  MAUDE report 24679748 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT THEIR PATIENT SUSTAINED A BLISTER AT THE TREATMENT SITE FOLLOWING THE USE OF THE ALMA HARMONY SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION WHICH DETERMINED THAT A BURN HAD OCCURRED AND WAS LIKELY DUE TO EXCESSIVE ENERGY. THE INVESTIGATION FOUND THAT THE BURN, WHICH WAS REPORTED BY THE USER FACILITY AS A BLISTER, WOULD LIKELY RESULT IN A PERMANENT SCAR. THEREFORE, WE ARE REPORTING THIS IN GOOD FAITH. THE CLEARSKIN HANDPIECE USED WITH THE ALMA HARMONY SYSTEM DURING THE TREATMENT WAS RETRIEVED FOR INSPECTION AS PART OF THE INVESTIGATION. THE DEVICE WAS FOUND TO HAVE MET MANUFACTURER'S SPECIFICATIONS.

  Patient problems: Burn(s)

  MAUDE report 24651332 ↗
• InjuryFeb 19, 2026Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION AND DETERMINED THAT THE BURN WILL LIKELY RESOLVE OVER TIME, BUT THE USER FACILITY HAS NOT RESPONDED TO MULTIPLE ATTEMPTS MADE BY ALMA LASERS INC. TO CONFIRM PATIENT HEALING. THEREFORE, WE ARE REPORTING THIS IN GOOD FAITH. ADDITIONALLY, ALMA LASERS INC. HAS MADE DUE DILIGENCE EFFORTS TO OBTAIN THE DEVICE FOR FURTHER EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY.

  Patient problems: Burn(s)

  MAUDE report 24393518 ↗
• InjuryFeb 19, 2026Use of Incorrect Control/Treatment Settings

  THE IMPORTER REPORTED THAT A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM.

  Patient problems: Burn(s)

  MAUDE report 24389612 ↗
• InjuryFeb 11, 2026Insufficient Device Problem Information

  THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM. THE FACILITY FURTHER REPORTED THAT THE CLEARSKIN HANDPIECE USED WITH THE ALMA HARMONY SYSTEM DURING THE TREATMENT BEGAN LEAKING WATER AFTER THE BURN OCCURRED.

  Patient problems: Burn(s)

  MAUDE report 24316818 ↗
• InjuryFeb 9, 2026Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM. THE FACILITY FURTHER REPORTED THAT THE CLEARSKIN HANDPIECE USED WITH THE ALMA HARMONY SYSTEM DURING THE TREATMENT BEGAN LEAKING WATER AFTER THE BURN OCCURRED. ALMA LASERS INC. CONDUCTED AN INITIAL INVESTIGATION AND DETERMINED THAT THE REPORTED BURN APPEARED SUPERFICIAL AND WAS EXPECTED TO RESOLVE. DURING FOLLOW-UP COMMUNICATION WITH THE USER FACILITY ON FEBRUARY 5, 2026, THE FACILITY ALLEGED THAT THE PATIENT SUBSEQUENTLY DEVELOPED A SCAR AS A RESULT OF THE BURN. NO UPDATED PHOTOGRAPHS OR ADDITIONAL CLINICAL DOCUMENTATION WERE PROVIDED TO SUPPORT THIS ALLEGATION. THIS EVENT IS BEING REPORTED IN GOOD FAITH. ALMA LASERS INC. HAS MADE DUE DILIGENCE EFFORTS TO OBTAIN THE DEVICE FOR FURTHER EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED BY THE USER FACILITY.

  Patient problems: Burn(s)

  MAUDE report 24301032 ↗
• InjuryNov 17, 2025Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information; Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information

  THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS AND BLISTERING AT THE TREATMENT SITE RESULTING SKIN DISCOLORATION FOLLOWING USE OF THE ALMA HARMONY SYSTEM.

  Patient problems: Blister; Burn(s); Skin Discoloration

  MAUDE report 23573479 ↗
• InjuryNov 13, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  FOLLOWING USE OF THE ALMA HARMONY SYSTEM AT A USER FACILITY, A PATIENT EXPERIENCED BURNS AND BLISTERING AT THE TREATMENT SITE. INVESTIGATION BY ALMA LASERS INC. FOUND THAT THE RESULTING SKIN DISCOLORATION SHOULD RESOLVE WITH APPROPRIATE CARE, HOWEVER, RECOVERY MAY TAKE SEVERAL MONTHS. THEREFORE, THIS INCIDENT IS BEING REPORTED IN GOOD FAITH.

  Patient problems: Skin Discoloration

  MAUDE report 23544047 ↗
• InjuryOct 22, 2025Failure to Deliver Energy; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Failure to Deliver Energy; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT ONE OF THEIR PATIENTS EXPERIENCED A SIGNIFICANT BURN AT THE TREATMENT SITE FOLLOWING THE USE OF THE ALMA HARMONY SYSTEM.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23359979 ↗
• InjuryOct 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT ONE OF THEIR PATIENTS EXPERIENCED A SIGNIFICANT BURN AT THE TREATMENT SITE FOLLOWING THE USE OF THE ALMA HARMONY SYSTEM. THE INVESTIGATION PERFORMED BY ALMA LASERS INC. DETERMINED THE INJURY TO BE A SECOND DEGREE BURN, THEREFORE WE ARE REPORTING THIS IN GOOD FAITH.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23342418 ↗
• InjuryMay 7, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS AND BLISTERS AT THE TREATMENT SITE FOLLOWING USE OF THE ALMA HARMONY SYSTEM.

  Patient problems: Burn(s)

  MAUDE report 21977296 ↗
• InjuryApr 23, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS AND BLISTERS AT THE TREATMENT SITE FOLLOWING THE USE OF THE ALMA HARMONY SYSTEM.

  Patient problems: Burn(s)

  MAUDE report 21894676 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DISTRIBUTOR REPORTED THE PATIENT EXPERIENCED A BURN POST TATTOO REMOVAL TREATMENT WITH THE ALMA HARMONY SYSTEM.

  Patient problems: Blister; Burn(s); Skin Erosion

  MAUDE report 21372267 ↗