Empower H35 PVMS00052Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08033945938185), received between Nov 14, 2018 and Nov 2, 2022 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Output Problem” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 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 15715003 ↗
• MalfunctionOct 21, 2022Electrical /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 15649162 ↗
• MalfunctionSep 29, 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 15507582 ↗
• MalfunctionSep 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  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 15334950 ↗
• MalfunctionAug 23, 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 15273563 ↗
• MalfunctionAug 9, 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 15189934 ↗
• 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 14711268 ↗
• MalfunctionMay 12, 2022Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14367717 ↗
• MalfunctionApr 7, 2022Failure to Deliver Energy; No Device Output; Failure to Deliver Energy; No Device Output

  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 14039689 ↗
• MalfunctionApr 5, 2022Output Problem; Output Problem

  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 14014957 ↗
• MalfunctionFeb 7, 2022Energy Output Problem; Energy 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 13469804 ↗
• MalfunctionDec 21, 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 13050787 ↗
• MalfunctionNov 23, 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 12861418 ↗
• 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 12475123 ↗
• MalfunctionAug 23, 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 12352270 ↗
• MalfunctionAug 12, 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 12311708 ↗
• MalfunctionJul 15, 2021Optical Problem; Output Problem; Optical 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 12173768 ↗
• MalfunctionJun 3, 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 11930569 ↗
• MalfunctionApr 30, 2021Use of Device 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 11752117 ↗
• MalfunctionApr 30, 2021Moisture or Humidity Problem; Output Problem

  THE LASER SYSTEM STOPPED DUE TO LACK OF WATER IN THE HYDRAULIC CIRCUIT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752113 ↗
• MalfunctionAug 26, 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 10454690 ↗
• MalfunctionAug 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 Known Impact Or Consequence To Patient

  MAUDE report 10377587 ↗
• MalfunctionJul 30, 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 10344248 ↗
• MalfunctionJul 16, 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 10283307 ↗
• MalfunctionMar 20, 2020Defective Device; Calibration Problem; Calibration 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 Consequences Or Impact To Patient

  MAUDE report 9860786 ↗