EmBodyPlus (Tite) HP AG608083ARecalls & reported problems
Inmode M.D Ltd · EmBodyPlus (Tite) HP · Class 2
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 07290016633511), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Use of Device Problem; Use of Device Problem
A FEMALE PATIENT PRESENTING WITH A ROUNDISH FULL THICKNESS BURN OF APPROXIMATELY 1.5CM IN DIAMETER ON HER LOWER ABDOMEN FOLLOWING TREATMENT WITH TITE APPLICATOR. THE BURN IS SITUATED IN THE CENTER OF A PRE-EXISTING SCAR THAT VERTICALLY CROSSES THE LOWER ABDOMEN, GOING FROM THE NAVEL DOWNWARDS.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 23603788 ↗
Other Massager, Vacuum, Radio Frequency Induced Heat devices
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- Face Applicator (Cheek Right) AG608275AInmode M.D Ltd · Massager, Vacuum, Radio Frequency Induced Heat2 reports
- NUERA TIGHT APMD140Bios Srl · Massager, Vacuum, Radio Frequency Induced Heat2 reports
- Venus Bliss BL000001Venus Concept Inc. · Massager, Vacuum, Radio Frequency Induced Heat1 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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