Empower H100 EMP-H100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08033945938918), received between Apr 11, 2019 and Jan 20, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Output 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  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 13304090 ↗
• MalfunctionJun 24, 2021Power Problem; Power 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 12063113 ↗
• MalfunctionJun 24, 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 12063101 ↗
• MalfunctionOct 2, 2020Appropriate Device Problem Term/Code Not Available; 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 10618595 ↗
• MalfunctionJul 22, 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 Known Impact Or Consequence To Patient

  MAUDE report 10308092 ↗
• MalfunctionMar 4, 2020Output 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 9785967 ↗
• MalfunctionApr 11, 2019Therapeutic or Diagnostic Output Failure

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8503993 ↗