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CHATTANOOGA 27840Recalls & reported problems

Djo, LLC · APPLICATOR SINGLE 850NM 100MW · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912293990), received between Mar 9, 2020 and Apr 15, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property 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

Device problems

  • Electrical /Electronic Property Problem1
  • Power Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 15, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED THAT THE "OUTPUT WAS TOO HIGH, REQUIRES CALIBRATION." THERE WAS NO REPORTED PATIENT HARM. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9964811 ↗
  • MalfunctionMar 9, 2020Power Problem; Power Problem

    IT WAS REPORTED THAT "POWER OUTPUT IS TOO HIGH, GETTING 150MW (MEGAWATTS) ON A 100MW APPLICATOR". THERE WAS NO REPORTED PATIENT HARM. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9805355 ↗

Other Lamp, infrared, therapeutic heating devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.