DAAVLIN Phothera 600-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810182930305), received between Apr 2, 2026 and Apr 2, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (1 report).

1 other recall cover devices cleared under the same FDA submission (K212510); they may or may not involve this specific model.

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.

• MalfunctionApr 2, 2026Use of Incorrect Control/Treatment Settings

  PATIENT'S SETTINGS WERE NOT SUCCESSFULLY SAVED WITH THE CHANGED MIN ON OF 10, AND ON THE FIRST TREATMENT (NOMINALLY 200MJ FRONT AND BACK), THE DEVICE DELIVERED LIGHT FOR 1:02 AND 1:56. PATIENT HAD SIGNIFICANT ERYTHEMA AND REACHED OUT TO THEIR HCP AT GEISSINGER.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24767421 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K212510. One submission often covers many models, so check the product and lot details in each record.

• Z-2743-2026 · Mar 5, 2026 · Open, Classified
  Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders