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18ch T/R Knee Coil Q7000074Recalls & reported problems

Quality Electrodynamics LLC · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00814848020003), received between Mar 31, 2020 and Mar 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Device problems

  • Improper or Incorrect Procedure or Method1

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.

  • InjuryMar 31, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    PATIENT EXPERIENCED A BURN AFTER A KNEE EXAM USING A 3T 18CH KNEE COIL WITH A GE 3.0T SIGNA ARCHITECT MRI SYSTEM. THE BURN WAS 2-3 INCHES IN DIAMETER, WITH REDNESS AND FORMED A BLISTER AFTER PATIENT LEFT THE SITE. BURN WAS >75% PARTIAL THICKNESS. PATIENT WAS SEEN BY A PHYSICIAN AND DIAGNOSED WITH A SECOND DEGREE BURN WHICH WAS TREATED WITH FIRST AID AND OINTMENT. BURN WAS HEALING WITHOUT FURTHER MEDICAL TREATMENT. PATIENT HAD A KNEE EXAM ON (B)(6) 2020 AND SENT A LETTER TO THE MRI FACILITY ON 13 FEBRUARY 2020 STATING THAT SHE EXPERIENCED A BURN ON HER RIGHT KNEE. THE PATIENT STATED SHE FELT WARMTH AND TINGLING DURING THE EXAM BUT CONTINUED THE EXAM. GE (THE MR SYSTEM MANUFACTURER) WAS NOTIFIED OF THE BURN BY THE MEDICAL FACILITY AND THEN THEY SUBSEQUENTLY NOTIFIED QED ON 05 MAR 2020.

    Patient problems: Partial thickness (Second Degree) Burn

    MAUDE report 9903853 ↗

Other Coil, Magnetic Resonance, Specialty devices

All Coil, Magnetic Resonance, Specialty devices →

Sources and updates

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