Multidiode Derma 1470 PDMS00203Recalls & reported problems
Quanta System SPA · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033945934330), received between Oct 16, 2018 and May 13, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Device” (1 report).
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
Device problems
- Defective Device1
- Protective Measures Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2019Defective Device
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT ANYMORE. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8603252 ↗MalfunctionMay 13, 2019Therapeutic or Diagnostic Output Failure
THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT ANYMORE. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8603245 ↗MalfunctionOct 16, 2018Protective Measures Problem
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 7968449 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.