Hybrid System 70W 120V 50/60 HZRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 17290110122109), received between Dec 12, 2024 and Jul 27, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Use of Incorrect Control/Treatment Settings

  A user facility reported that a patient sustained a burn at the treatment site following use of the Hybrid System. Alma Lasers Inc. conducted an investigation and requested the Hybrid System and Proscan Applicator used during treatment for evaluation. Upon inspection the devices were found to have met manufacturers' specifications and were returned to the customer. The invesitgation also included a clinical evaluation, which determined that the event was most likely attributable to user technique. However, as the injury is expected to result in scarring, this event is being reported in good faith.

  Patient problems: Burn(s)

  MAUDE report 50010299 ↗
• InjuryDec 10, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  THE IMPORTER REPORTED THAT FOLLOWING USE OF THE HYBRID SYSTEM AT A USER FACILITY, A PATIENT EXPERIENCED A BURN AT THE TREATMENT SITE.

  Patient problems: Burn(s)

  MAUDE report 23768671 ↗
• InjuryDec 8, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  FOLLOWING USE OF THE HYBRID SYSTEM AT A USER FACILITY, A PATIENT EXPERIENCED A BURN AT THE TREATMENT SITE. INVESTIGATION BY ALMA LASERS INC. FOUND THAT THE BURN WILL LIKELY LEAVE A PERMANENT SCAR.

  Patient problems: Burn(s)

  MAUDE report 23752605 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT EXPERIENCED A BURN POST HYBRID TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 22480469 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPORTER REPORTED THAT A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED POST INFLAMMATORY HYPERPIGMENTATION IN THE TREATMENT AREA FOLLOWING THE USE OF THE HYBRID SYSTEM. IT WAS IMPOSSIBLE TO CONFIRM THE PATIENT'S POST INFLAMMATORY HYPERPIGMENTATION HAS RESOLVED, THEREFORE WE ARE REPORTING IN GOOD FAITH.

  Patient problems: Skin Disorders

  MAUDE report 22340856 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED POST INFLAMMATORY HYPERPIGMENTATION IN THE TREATMENT AREA FOLLOWING THE USE OF THE HYBRID SYSTEM. WE HAVE BEEN UNABLE TO CONFIRM THE PATIENT'S POST INFLAMMATORY HYPERPIGMENTATION HAS RESOLVED; THEREFORE WE ARE REPORTING THIS IN GOOD FAITH.

  Patient problems: Skin Disorders

  MAUDE report 22074284 ↗
• InjuryDec 12, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ABOUT A BURN AFTER HYBRID LASER TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 20914629 ↗