BodyTite Pro AG604881ARecalls & reported problems
Inmode M.D Ltd · The lnMode RF System generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The lnMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The handpiece is comprised of a disposable, single use plastic handle with internal and external electrodes. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290016633368), received between Sep 15, 2024 and Aug 27, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (3 reports).
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
- Use of Device Problem3
Patient problems
- Full thickness (Third Degree) Burn2
- Cellulitis1
- Necrosis1
- Wound Dehiscence1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Use of Device Problem
Incision ports on abdomen and flanks not healing 10 months post procedure that combined liposuction and BodyTite. According to the patient, after he complained to the doctor that the incisions were not closing, he was treated with antibiotics and drainage attempt was performed. 8 months post tx he received steroids injections into each incision port. The patient also reported contour irregularity near his navel which is attributed to an excessive liposuction, not related to the BodyTite device.
Patient problems: Necrosis; Wound Dehiscence
MAUDE report 50471481 ↗InjurySep 17, 2024Use of Device Problem; Use of Device Problem
FULL THICKNESS BURNS ON MEDIAL THIGHS, WITH SECONDARY INFECTION, POST BODYTITE PROCEDURE.
Patient problems: Cellulitis; Full thickness (Third Degree) Burn
MAUDE report 20234934 ↗InjurySep 15, 2024Use of Device Problem; Use of Device Problem
FULL THICKNESS BURNS ON MEDIAL THIGH POST BODYTITE PROCEDURE.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 20220333 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.