Panosol 6-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850054882141), received between Dec 13, 2024 and Dec 13, 2024 — 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. 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.

• InjuryDec 13, 2024Use of Incorrect Control/Treatment Settings; Use of Device Problem; Use of Incorrect Control/Treatment Settings; Use of Device Problem

  PATIENT HAS BEEN DIAGNOSED WITH PSORIASIS VULGARIS (L40.0). HER DOCTOR PRESCRIBED THE USE OF A PANOSL 63D (ULTRAVIOLET LIGHT THERAPY SYSTEM) TO TREAT HER CONDITION AT HOME BECAUSE OF FREQUENT FLAREUPS OF THE DISEASE. PATIENT WAS ADVISED THAT SHE WOULD NEED 2-3 TREATMENTS PER WEEK AND THAT SHE WOULD BE CONTACTED BY A DOCTOR TO PROVIDE MORE DETAIL REGARDING HER TREATMENT PROTOCOL. UPON RECEIPT OF HER EQUIPMENT, THE PATIENT STILL HAD NOT RECEIVED THE CALL FROM THE PHYSICIAN AND DECIDED TO BEGIN TREATMENT ON HER OWN. USING HER PREVIOUS TANNING EXPERIENCE AS A BASELINE, THE PATIENT DECIDED TO USE AN INITIAL TREATMENT TIME OF SEVEN MINUTES. SHE DID NOT REFER TO THE RECOMMENDED PROTOCOLS INCLUDED IN THE DEVICE OPERATIONS MANUAL NOR CONSULT HER PHYSICIAN OR NATBIO PRIOR TO THE TREATMENT. THIS ARBITRARY TREATMENT TIME DOES NOT CORRESPOND TO THE RECOMMENDED PROTOCOL FOR HER SKIN TYPE (FITZPATRICK SKIN TYPE II) NOR ANY OTHER PHOTOTHERAPY PROTOCOL. AS A RESULT, THE PATIENT RECEIVED FIRST DEGREE BURNS ACROSS HER BODY. SHE SOUGHT TREATMENT FOR HER BURNS AT A LOCAL EMERGENCY ROOM AND WAS PRESCRIBED IBUPROFEN AND PYREGESIC TO TREAT THE INJURIES. HER CURRENT CONDITION IS MUCH IMPROVED WITH SKIN RED

  Patient problems: Burn(s)

  MAUDE report 20925440 ↗