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CHATTANOOGA 27816Recalls & reported problems

Djo, LLC · APPLICATOR 13CLS 3X200MW 715MW · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912293891), received between Feb 3, 2020 and Feb 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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

  • Overheating of Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 3, 2020Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE "OUTPUT IS HOT AND CAUSING CUSTOMER TO PULL AWAY FROM TREATMENT." THERE WAS NO REPORTED PATIENT HARM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9659421 ↗

Other Lamp, infrared, therapeutic heating devices

All Lamp, infrared, therapeutic heating devices →

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