Ulthera System Control Unit UC-1 Rev. ERecalls & reported problems
Ulthera, Inc. · Class 2
All models of Ulthera System Control Unit (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840763100186), received between Dec 6, 2016 and Dec 6, 2016 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Scar Tissue1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PRACTICE REPORTED TO MDIC ON (B)(6) 2016 A FEMALE PATIENT WHO HAD HORIZONTAL LINES AND DIVOTS ON HER CHEST AREA 6 MONTHS POST DÉCOLLETAGE TREATMENT (B)(6) 2016. MEDICAL INTERVENTION WAS RECOMMENDED TO THE PATIENT FOR FULL RESOLUTION THUS CONSIDERED A PERMANENT INJURY. PER ULTHERA IFU, THE POSSIBILITY OF SCAR FORMATION MAY EXIST IF INCORRECT TREATMENT TECHNIQUE IS USED. REVIEW OF THE SUPPORT LOG SHOWS NO DEVICE MALFUNCTION.
Patient problems: Scar Tissue
MAUDE report 6149839 ↗
Other Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption devices
- Sofwave FG00001Sofwave Medical Ltd · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption12 reports
- Ulthera System Control Unit UC-1 Rev. DUlthera, Inc. · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption7 reports
- Ulthera System Control Unit UC-1 Rev RUlthera, Inc. · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption6 reports
- Ulthera System Control Unit PRIME UC-1 Control Unit (PRIME) Rev. AUlthera, Inc. · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption4 reports
- Ulthera System Control Unit UC-1 Rev. FUlthera, Inc. · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption2 reports
- Ulthera System Control Unit UC-1 Rev. LUlthera, Inc. · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption2 reports
- Ulthera System Transducer UT-1 Rev NUlthera, Inc. · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption2 reports
- Ulthera System Control Unit UC-1 Rev. CUlthera, Inc. · Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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