CO2 New Scanner system 100-120V 30WRecalls & reported problems
Alma Lasers Ltd. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 17290110120952), received between Jun 28, 2018 and Jan 8, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information3
Patient problems
- Burn(s)1
- Herpes1
- Pain1
- Scar Tissue1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT SUBMITTED A SELF REPORT (MW5162379) TO FDA ABOUT A SCAR TISSUE FOLLOWING THE PIXEL CO2 TREATMENT ON 2021.
Patient problems: Pain; Scar Tissue
MAUDE report 21101000 ↗InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
AS PER THE FACILITY, THE PATIENT SUSTAINED SLIGHT BURNS ON THE EXTERNAL LABIA.
Patient problems: Burn(s)
MAUDE report 8460606 ↗InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE SUSPECTED DEVICE WAS USED ON PATIENT'S NECK, FACE AND CHEST. AS PER THE FACILITY, THE ALLEGED INJURY WAS DIAGNOSED AS COLD SORES ON FACE AND NECK. THE FACILITY DID NOT PROVIDE ANY TREATMENT/HANDPIECE DETAILS AND WAS UNRESPONSIVE TO ALMA'S MULTIPLE ATTEMPTS TO OBTAIN INFORMATION.
Patient problems: Herpes
MAUDE report 7648048 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.