Empower H65Recalls & reported problems across all models
Quanta System SPA · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Empower H65 by Quanta System SPA in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2018 and Nov 28, 2022 — classified as 85 malfunctions.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Empower H65 problems
Device problems
- Therapeutic or Diagnostic Output Failure32
- Output Problem23
- Defective Device11
- Appropriate Device Problem Term/Code Not Available7
- Electrical /Electronic Property Problem7
- Optical Problem2
- Complete Loss of Power1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- No Known Impact Or Consequence To Patient35
Empower H65 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Empower H65 PVMS00051Powered Laser Surgical Instrument59 reports
- Empower H65 EMP-H65Powered Laser Surgical Instrument26 reports
Recent Empower H65 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2022Output Problem; Output Problem
THE DEVICE HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15868562 ↗MalfunctionNov 28, 2022Output Problem; Output Problem
THE DEVICE HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15868551 ↗MalfunctionNov 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW THE PATIENT TO USE IT. NO ADVERSE EFFECTS TO PATIENT HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15728055 ↗MalfunctionSep 14, 2022Output Problem; Output Problem
LASER OVERHEATING AND SHUTTING DOWN DURING SURGICAL PROCEDURE CAUSING TREATMENT DELAY. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15415830 ↗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 30, 2022Defective 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 14869716 ↗MalfunctionJun 23, 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 14785549 ↗MalfunctionJun 16, 2022Optical Problem; Optical 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 14711267 ↗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 ↗MalfunctionFeb 24, 2022Therapeutic or Diagnostic Output Failure
THE LASER 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 13590668 ↗MalfunctionFeb 4, 2022Therapeutic 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 13451390 ↗MalfunctionJan 25, 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 13342784 ↗MalfunctionJan 25, 2022Infusion or Flow Problem; Output Problem; Infusion or Flow 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 13342773 ↗
Other Quanta System SPA products
All Quanta System SPA devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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