GE HD T/R Quad Extremity CoilRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838067110), received between Feb 10, 2020 and Mar 31, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 31, 2020Defective Device; Connection Problem; Therapeutic or Diagnostic Output Failure

  THE COIL WAS PREVIOUSLY IN USE AT TURKISH SITE: BILIM OZEL TIP MERKEZI. THE END USER CALLED THE DISTRIBUTOR (GE) TO REPORT THAT COIL HAD "NO CONNECTIVITY". GE FOUND THAT A MCQA TEST FAILED AND A CABLE REPLACEMENT DID NOT RESOLVE THE ISSUE. GE REPLACED THE COIL AND SENT THE DEFECTIVE COIL TO INVIVO FOR SERVICE AND REPAIR. UPON ARRIVAL AT INVIVO, THE SERVICE AND REPAIR DEPARTMENT IDENTIFIED WARPED HOUSING ON THE QLE COIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9907676 ↗
• MalfunctionFeb 10, 2020Break

  COIL WAS DELIVERED TO INVIVO SERVICE AND REPAIR. UPON RECEIPT, THERMAL DAMAGE WAS NOTED ON CHIMNEY HOUSING. NOTE: THE END USER HAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT WITH RESPECT TO THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 9689805 ↗