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Phoenix CO2Recalls & reported problems

Rohrer Aesthetics, LLC · The equipmnent is used for- human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otolaryngology. · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860564000324), received between Aug 5, 2022 and Feb 17, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method1
  • Use of Device Problem1

Patient problems

  • Burn(s)1
  • Full thickness (Third Degree) Burn1
  • Skin Discoloration1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 17, 2026Use of Device Problem

    3 DAYS POST TREATMENT OF SKIN RESURFACING THE PATIENT REPORTED INFLAMMATION, ERYTHEMA, TISSUE EROSION, AND CRUSTING. PROVIDER INSTRUCTED PATIENT TO KEEP CLOTHING OFF SKIN, USE GENTLY CLEANSER, BYACYN SPRAY AND OCCLUSIVE. PATIENT REFERRED TO URGENT CARE BY PROVIDER FOR ASSESSMENT. PATIENT WAS PRESCRIBED BACITRACIN, KEFLEX AND BACTRIM. PATIENT WAS GIVEN WOUND CARE INSTRUCTIONS BY URGENT CARE PROVIDER. PROVIDER REPORTED A MARKED IMPROVEMENT NOTED WITHIN 48 HOURS.

    Patient problems: Burn(s); Skin Discoloration

    MAUDE report 24371655 ↗
  • InjuryAug 5, 2022Improper or Incorrect Procedure or Method

    A ROHRER CUSTOMER INCORRECTLY TREATED A PATIENT WITH A CO2 DEVICE CAUSING 3RD DEGREE BURNS TO THE PATIENT. THE CUSTOMER HAD NOT RECEIVED ANY TRAINING FOR THE DEVICE. HOWEVER, THE CUSTOMER DECIDED TO TREAT A PATIENT WITHOUT TRAINING OF THE DEVICE. THE PATIENT WAS ADMITTED TO THE BURN UNIT 2 DAYS AFTER THE ADVERSE EVENT. OUR SERVICE ENGINEER INSPECTED THE DEVICE ON (B)(6) 2022 AND FOUND THE DEVICE TO BE IN COMPLETE WORKING ORDER. THE LASER MET ALL CALIBRATION AND POWER STANDARDS AS SET BY THE FDA. THE CUSTOMER HAS NOT BEEN FORTHCOMING WITH DETAILS OF THE PATIENT. I WAS ONLY ABLE TO ASCERTAIN BACKGROUND AND ETHNICITY FROM PICTURES.

    Patient problems: Full thickness (Third Degree) Burn

    MAUDE report 15180283 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.