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CHATTANOOGA 2796Recalls & reported problems

Djo, LLC · VECTRA GENISYS 4CH COMBO US STD W/CART · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912294607), received between Jun 14, 2023 and Jun 14, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Energy Output 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

  • Energy Output Problem1

Patient problems

  • Partial thickness (Second Degree) Burn1

Recent adverse event reports

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

  • InjuryJun 14, 2023Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THE UNIT AUTOMATICALLY SHUTS OFF WHEN THE INTENSITY IS ABOVE 40 AND HAPPENS EVER 5-10 MINUTES. IT WAS ALSO REPORTED THAT A PATIENT ALLEGEDLY RECEIVED A 2ND DEGREE BURN.

    Patient problems: Partial thickness (Second Degree) Burn

    MAUDE report 17131890 ↗

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