UltraPulse α O.R.Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109145037), received between Sep 23, 2026 and Sep 23, 2026 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Insufficient Device Problem Information; Missing Information

  Lumenis received an adverse event report on a patient who sustained injury following treatment by UltraPulse Alpha device. Per the customer, while waiting for the replacement, the doctor continued using the system, and a very serious event occurred. Although the only known intermittent fault was FPGA Communication Error #58, the system generated an abnormal laser pulse with an unexpected power peak during treatment.

  Patient problems: Insufficient Information

  MAUDE report 50869102 ↗