Empower H65 EMP-H65Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08033945938901), received between Aug 1, 2019 and Aug 24, 2022 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Output Problem” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2022Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281100 ↗
• MalfunctionJun 16, 2022Defective Device

  THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14711266 ↗
• MalfunctionJun 1, 2022Defective Device

  THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14560456 ↗
• MalfunctionApr 19, 2022Defective Device

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141876 ↗
• MalfunctionJan 20, 2022Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13304087 ↗
• MalfunctionDec 16, 2021Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017685 ↗
• MalfunctionOct 25, 2021Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689039 ↗
• MalfunctionOct 20, 2021Device Sensing Problem; Device Sensing Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12663413 ↗
• MalfunctionOct 14, 2021Failure to Power Up; Failure to Power Up

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631342 ↗
• MalfunctionSep 15, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475125 ↗
• MalfunctionSep 15, 2021Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475124 ↗
• MalfunctionAug 23, 2021Optical Problem; Optical Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352271 ↗
• MalfunctionAug 18, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335284 ↗
• MalfunctionJul 16, 2021Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12184539 ↗
• MalfunctionJul 15, 2021Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177919 ↗
• MalfunctionJul 2, 2021Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108590 ↗
• MalfunctionJun 16, 2021Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009603 ↗
• MalfunctionFeb 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342787 ↗
• MalfunctionFeb 16, 2021Output Problem; Therapeutic or Diagnostic Output Failure

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY.NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332682 ↗
• MalfunctionDec 7, 2020Therapeutic or Diagnostic Output Failure

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10959232 ↗
• MalfunctionNov 13, 2020Therapeutic or Diagnostic Output Failure

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10836956 ↗
• MalfunctionOct 29, 2020Therapeutic or Diagnostic Output Failure

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10756294 ↗
• MalfunctionMar 24, 2020Electrical /Electronic Property Problem; Therapeutic or Diagnostic Output Failure; Electrical /Electronic Property Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9872822 ↗
• MalfunctionMar 20, 2020Defective Device

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9860697 ↗
• MalfunctionOct 30, 2019Therapeutic or Diagnostic Output Failure

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9255653 ↗