Luxora System AG613237ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290019863267), received between Aug 31, 2026 and Aug 31, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Insufficient Device Problem Information

  The clinic reported of a female patient sustaining an adverse event following Quantum RF procedure, presumably neurapraxia.

  Patient problems: Insufficient Information; Peripheral Nervous Injury

  MAUDE report 50515330 ↗
• InjuryAug 31, 2026Insufficient Device Problem Information

  The clinic reported of a female patient sustaining an adverse event following Quantum RF procedure, presumably neurapraxia.

  Patient problems: Insufficient Information; Peripheral Nervous Injury

  MAUDE report 50515326 ↗
• InjuryAug 31, 2026Insufficient Device Problem Information

  The patient first underwent Quantum procedure on her pubic region and developed a seroma. Additionally, the patient was treated on her medial thigh with Quantum RF, where a nodule was later observed. Per latest update, the nodule resolved with PIH as a sequela.

  Patient problems: Hyperpigmentation; Nodule; Seroma

  MAUDE report 50515323 ↗