InMode AG606991ARecalls & reported problems
Inmode M.D Ltd · InMode System 2 - color 1 Optimas · 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 07290016633375), received between Mar 1, 2022 and Mar 1, 2022 — 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
- Nerve Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem
MANDIBULAR NERVE PALSY ON THE RIGHT SIDE, POST MORPHEUS8 TREATMENT MOST PROBABLY DUE TO THE ADMINISTRATION OF NERVE BLOCK. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Nerve Damage
MAUDE report 13652383 ↗
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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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