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
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- MAGNETOM Skyra 10849580Siemens Healthcare GmbH · Coil, magnetic resonance, specialty2 recalls2 reports
- MAGNETOM Altea 11410371Siemens Healthcare GmbH · Coil, magnetic resonance, specialty1 recall2 reports
- MAGNETOM Spectra 10837643Siemens Shenzhen Magnetic Resonance Ltd. · Coil, magnetic resonance, specialty1 recall1 report
- MR Coils dS Breast 16ch 3.0TPhilips Medical Systems Nederland B.V. · Coil, Magnetic Resonance, Specialty1 recall0 reports
- Invivo 45353028072Philips Ds North America LLC · Coil, magnetic resonance, specialty1 recall0 reports
- Philips dS Breast 7ch 3.0TPhilips Ds North America LLC · Coil, magnetic resonance, specialty1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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