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CHATTANOOGA 6000Recalls & reported problems

Djo, LLC · VECTRA NEO · Class 2

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912358743), received between Oct 23, 2019 and Oct 20, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (2 reports).

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

  • Energy Output Problem2
  • Electrical /Electronic Property Problem1
  • Intermittent Energy Output1
  • No Apparent Adverse Event1
  • Power Conditioning Problem1
  • Unintended Electrical Shock1
  • Unintended Power Up1

Patient problems

  • No Consequences Or Impact To Patient3
  • Electric Shock2
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 20, 2022Unintended Power Up; Electrical /Electronic Property Problem; Unintended Power Up; Electrical /Electronic Property Problem

    IT WAS REPORTED THAT THE UNIT'S INTENSITY ALLEGEDLY WAS SPIKING AND SHOCKING PATIENTS WHEN ADJUSTING INTENSITY KNOB.

    Patient problems: Electric Shock

    MAUDE report 15643064 ↗
  • MalfunctionSep 23, 2020No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED THAT THE "MUSCLE STIM INTENSITY INCREASES RANDOMLY." DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10575070 ↗
  • MalfunctionJul 27, 2020Unintended Electrical Shock; Unintended Electrical Shock

    IT WAS REPORTED THAT THE DEVICE SHOCKED A PATIENT WHILE IN ELECTROTHERAPY TREATMENT. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Patient problems: Electric Shock

    MAUDE report 10326535 ↗
  • MalfunctionDec 30, 2019Intermittent Energy Output; Intermittent Energy Output

    IT WAS REPORTED THAT THE "E-STIM MACHINE IS JUMPING WITH THE CURRENT BEING DELIVERED. CUSTOMER DOES NOT GET ANY ERROR CODE AND UNIT DOES NOT STOP TREATMENT. THEREFORE, SAFETY FEATURE FAIL TO ACTIVATE." THERE WAS NO REPORTED PATIENT HARM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9529951 ↗
  • MalfunctionNov 21, 2019Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT INTENSITY ON ELECTROSTIMULATION JUMPS UP WITHOUT WARNING DURING TREATMENT. THERE WAS REPORTEDLY NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9354170 ↗
  • MalfunctionNov 21, 2019Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT INTENSITY ON ELECTROSTIMULATION JUMPS UP WITHOUT WARNING DURING TREATMENT. THERE WAS REPORTEDLY NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9354148 ↗
  • MalfunctionOct 23, 2019Power Conditioning Problem; Power Conditioning Problem

    IT WAS REPORTED THAT UPON INCREASING THE INTENSITY, WHILE SET ON STIMULATION, THE UNIT RAISES ALL THE WAY TO ITS MAXIMUM. THE UNIT WAS QUICKLY TURNED OFF AND THERE WAS REPORTEDLY NO PATIENT HARM. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9225565 ↗

Other Stimulator, muscle, powered devices

All Stimulator, muscle, powered devices →

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