Ulthera System Control Unit UC-1 Rev. IRecalls & reported problems
Ulthera, Inc. · Class 2
All models of Ulthera System Control Unit (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00840763100223), received between Mar 23, 2017 and Oct 3, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Burn, Thermal1
- Facial Nerve Paralysis1
- Paresis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2015, A MERZ FIELD REPRESENTATIVE CONVEYED THAT THEY RECEIVED A CALL FROM A PRACTICE WHO REPORTED A PATIENT EXPERIENCING EXTREME PARESIS FOLLOWING A FULL FACE ULTHERA TREATMENT WITH CONTROL UNIT SERIAL NUMBER (B)(4), PERFORMED UNDER STANDARD PROTOCOL.
Patient problems: Facial Nerve Paralysis; Paresis
MAUDE report 6909706 ↗InjuryMar 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE HEALTH CARE PROVIDER REPORTED 9/8/2016 THAT A PATIENT HAD WELTS AS A RESULT OF HER (B)(6) 2016 CHEST TREATMENT. AS OF 3/15/2017 THE PATIENT WELTS REMAIN IN THE FORM OF A SCAR.
Patient problems: Burn, Thermal
MAUDE report 6429757 ↗
Other System, Imaging, Pulsed Echo, Ultrasonic devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed echo, ultrasonic1 recall8 deaths5,133 reports
- Site~Rite 8 Ultrasound System 9770600Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic629 reports
- Site-Rite 9770501Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic546 reports
- Transducer X8-2t 989605455171Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic8 recalls19 reports
- Transducer C10-3v 989605409562Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic7 recalls0 reports
- Site~Rite 8 Ultrasound System 9770600YBard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic330 reports
- Transducer C9-2 989605391092Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
- Transducer S5-1 989605412082Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page