Harmony XL Pro System 100-120V (Black/Grey)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 17290110120907), received between Mar 31, 2024 and Apr 14, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Use of Incorrect Control/Treatment Settings

  THE IMPORTER REPORTED THAT A USER FACILITY REPORTED THAT THEIR PATIENT SUSTAINED A BURN AND DEPIGMENTATION AT THE TREATMENT SITE FOLLOWING THE USE OF THE HARMONY XL PRO SYSTEM.

  Patient problems: Hypopigmentation

  MAUDE report 24868196 ↗
• InjuryApr 11, 2026Use of Incorrect Control/Treatment Settings

  A USER FACILITY REPORTED THAT THEIR PATIENT SUSTAINED A BURN AND DEPIGMENTATION AT THE TREATMENT SITE FOLLOWING THE USE OF THE HARMONY XL PRO SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION WHICH DETERMINED THAT THE BURN WITH SUBSEQUENT HYPOPIGMENTATION HAD LIKELY OCCURRED DUE TO USER TECHNIQUE. THE INVESTIGATION ALSO INDICATED REPIGMENTATION MAY OCCUR OVER TIME, THEREFORE WE ARE REPORTING THIS IN GOOD FAITH. THE DEVICE WAS REQUESTED FOR INSPECTION BUT THE CUSTOMER HAS NOT RETURNED THE DEVICE FOR INSPECTION OR RESPONDED TO THE DEVICE RETURN FOLLOW UP ATTEMPTS COMPLETED BY ALMA LASERS INC.

  Patient problems: Hypopigmentation

  MAUDE report 24848367 ↗
• InjuryFeb 18, 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 HARMONY XL PRO SYSTEM.

  Patient problems: Burn(s)

  MAUDE report 24377546 ↗
• InjuryFeb 17, 2026Use of Incorrect Control/Treatment Settings

  A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE HARMONY XL PRO SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION AND DETERMINED THAT THE BURN LIKELY OCCURRED DUE TO MULTIPLE STACKS OR MULTIPLE PASSES BEING PERFORMED AT THE TREATMENT SITE AND FOUND IIT WAS LIKELY TO RESULT IN A PERMANENT SCAR. ALMA LASERS INC. HAS MADE DUE TO 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 24373874 ↗
• InjuryApr 30, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS AT THE TREATMENT SITE FOLLOWING USE OF THE HARMONY XL PRO SYSTEM.

  Patient problems: Burn(s)

  MAUDE report 21934564 ↗
• InjuryFeb 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ABOUT A SECOND-DEGREE BURN FOLLOWING THE HARMONY XL PRO TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21384114 ↗
• InjuryJan 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THERE WAS A REPORT OF A SECOND DEGREE BURN POST TREATMENT WITH THE HARMONY XL PRO SYSTEM THAT WE HAVE BEEN UNABLE TO CONFIRM DUE TO LACK OF PHOTO EVIDENCE, THEREFORE WE ARE FILING THIS REPORT IN GOOD FAITH.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21183672 ↗
• InjuryNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ABOUT A HYPERPIGMENTATION FOLLOWING THE HARMONY XL PRO TREATMENT.

  Patient problems: Hyperpigmentation

  MAUDE report 20681248 ↗
• InjuryOct 29, 2024Optical Problem; Optical Problem

  IT WAS REPORTED ABOUT A BURN WITH POST INFLAMMATORY HYPERPIGMENTATION FOLLOWING THE HARMONY XL PRO HR TREATMENT.

  Patient problems: Burn(s); Hyperpigmentation

  MAUDE report 20556652 ↗
• InjuryOct 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ABOUT A BURN WITH HYPOPIGMENTATION FOLLOWING THE HARMONY XL PRO TREATMENT.

  Patient problems: Burn(s); Hypopigmentation

  MAUDE report 20543017 ↗
• InjuryAug 15, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED ABOUT SCARRING FOLLOWING THE OPUS GLIDE TREATMENT.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 19990733 ↗
• InjuryJul 1, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED ABOUT A HYPERPIGMENTATION, CRUSTING AND PEELING FOLLOWING THE HARMONY XL HAIR REMOVAL TREATMENT.

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 19642134 ↗
• InjuryJun 13, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED ABOUT A SCARRING FOLLOWING THE HARMONY XL TATTOO REMOVAL TREATMENT.

  Patient problems: Scar Tissue

  MAUDE report 19531162 ↗
• InjuryApr 19, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED ABOUT A BURN AND A BLISTER FOLLOWING THE HARMONY XL SHR TREATMENT.

  Patient problems: Blister; Burn(s)

  MAUDE report 19142598 ↗
• InjuryMar 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ABOUT A BURN AND A SCAR ON RIGHT CHEEK.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 19009283 ↗