Empower H35Recalls & 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
- 60
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Empower H35 by Quanta System SPA in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2018 and Nov 2, 2022 — classified as 60 malfunctions.
The most frequently reported specific device problem is “Output Problem” (20 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 H35 problems
Device problems
- Output Problem20
- Therapeutic or Diagnostic Output Failure17
- Defective Device6
- Electrical /Electronic Property Problem5
- Appropriate Device Problem Term/Code Not Available2
- Detachment of Device or Device Component2
- Energy Output Problem2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Known Impact Or Consequence To Patient23
- No Consequences Or Impact To Patient1
Empower H35 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Empower H35 PVMS00052Powered Laser Surgical Instrument33 reports
- Empower H35 EMP-H35Powered Laser Surgical Instrument27 reports
Recent Empower H35 adverse event reports
The 15 most recent reports across all models, 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 ↗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 15649157 ↗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 ↗MalfunctionJul 14, 2022Energy 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 15013259 ↗MalfunctionJun 23, 2022Communication or Transmission Problem; Communication or Transmission 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 14785548 ↗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 ↗
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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