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
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.