Ulthera System Transducer UT-1 Rev NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840763100865), received between Jun 17, 2022 and Jun 2, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Computer Operating System Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJun 2, 2023Image Display Error/Artifact; Dent in Material; Computer Operating System Problem; Noise, Audible; Image Display Error/Artifact; Dent in Material; Computer Operating System Problem; Noise, Audible

  ON (B)(6) 2023, A KOREAN AFFILIATE ALLEGED AN ADVERSE EVENT OCCURRED FOLLOWING ULTHERAPY TREATMENT. THIS SPONTANEOUS REPORT RECEIVED FROM A KOREAN PHYSICIAN IS CONCERNING A PATIENT OF UNKNOWN AGE AND GENDER. ACCORDING TO THE REPORT: "IT FEELS LIKE THE SHOT DIDN'T GO OUT AS IT SHOULD HAVE, AND THERE'S A BURN ON THE LEFT SIDE." PER THE REPORTING EMAIL, THE BURN IS ON THE LEFT SIDE OF THE PATIENT'S FACE, AND THE TREATMENT WAS PERFORMED ON (B)(6) 2023. ON 06-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED STATING A CODE G (NON-SPECIFIC HARDWARE ISSUE) OCCURRED DURING THE TREATMENT, AND THE PHYSICIAN ESTIMATED THE BURN TO BE SECOND-DEGREE AND RECOMMENDED THAT THE PATIENT BE TREATED AT A BURN HOSPITAL. ON 22-MAR-2023, THE KOREAN AFFILIATE REPORTED THAT THE PATIENT'S SYMPTOMS WERE "RESOLVING." THE FINAL OUTCOME OF THE EVENT WAS NOT REPORTED. A REVIEW OF THE SUPPORT LOG REVEALED 372 TOTAL LINES WERE DELIVERED DURING THIS TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WAS INITIALLY SUBMITTED UNDER AN INCORRECT MANUFACTURER FEI NUMBER: 3006560326-2023-00014.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17052202 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MERZ (B)(4) AFFILIATE REPORTED VIA EMAIL ON (B)(6) 2022 REGARDING AN ALLEGED ADVERSE EVENT FOLLOWING AN ULTHERAPY TREATMENT. ACCORDING TO THE REPORT, "39-YEAR-OLD PATIENT WITH NO MEDICAL OR SURGICAL HISTORY OF INTEREST. SHE COMES TO THE CONSULTATION FOR ULTHERAPY TREATMENT OF THE LOWER THIRD, SHE IS AWARE OF THE PROCESS, WHICH HAS ALREADY BEEN CARRIED OUT ON ANOTHER OCCASION IN ANOTHER COUNTRY. ON (B)(6) 2022 ULTHERAPY TREATMENT WAS PERFORMED ON THE LOWER 2/3 OF THE FACE AND NECK, 400 TOTAL LINES COMBINING TRANSDUCER 4-4.5 AT 1.20J AND 7-3.0 AT 0.30J. WELL TOLERATED TREATMENT WITH NO INCIDENTS DURING IT. AT THE END OF THE TREATMENT, THE PATIENT PRESENTED MODERATE ERYTHEMA AND DISCRETE EDEMATOUS LINES ON BOTH CHEEKS, HOME DIPROGENTA AND SUN PROTECTION WERE PRESCRIBED. ON FEBRUARY 28TH, THE PATIENT SENDS PHOTOS SHOWING INFLAMMATION, HEMATOMA AND LINEAR LESIONS MAINLY ON BOTH CHEEKS. DUE TO PERSONAL PROBLEMS, THE PATIENT DID NOT GO TO CONTROL UNTIL (B)(6) 2022, AN INFLAMMATORY PROCESS IS OBSERVED ABOVE THE USUAL, ERYTHEMA ON BOTH CHEEKS, HEMATOMA AND LINEAR LESIONS WITH LOSS OF CONTINUITY OF THE SKIN. SINCE THEN, PERIODIC CHECK-UPS HAVE BEEN CARRIED OUT ON THE PATIENT AND DIFFERENT

  Patient problems: Bruise/Contusion; Erythema; Scar Tissue; Wheal(s)

  MAUDE report 14738772 ↗