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MAGNETOM ESSENZA 10837633Recalls & reported problems

Siemens Shenzhen Magnetic Resonance Ltd. · MRI Scanner · Class 2

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869006772), received between Dec 17, 2020 and Jan 26, 2026 — classified as 2 injuries.

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

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Handling Problem1
  • Use of Device Problem1

Patient problems

  • Burn(s)1
  • Limb Fracture1

Recent adverse event reports

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

  • InjuryJan 26, 2026Device Handling Problem

    SIEMENS HEALTHINEERS WAS NOTIFIED OF AN INJURY INVOLVING THE MAGNETOM ESSENZA DOT (DE) SYSTEM. ACCORDING TO THE COMPLAINT REPORT, A NURSE SUSTAINED A FRACTURED HAND WHEN A SMALL NON-MR-COMPATIBLE OXYGEN CYLINDER WAS BROUGHT INTO THE MAGNET ROOM AND WAS ATTRACTED TO THE MAGNET. THE INJURY REQUIRED MEDICAL INTERVENTION (CASTING). THE PATIENT IS OTHERWISE REPORTED AS HEALTHY. THE MR SYSTEM ITSELF WAS NOT DAMAGED; THE OBJECT WAS REMOVED AFTER A RAMP-DOWN/RAMP-UP CYCLE. NO FURTHER INFORMATION ABOUT THE SEVERITY OR MEDICAL TREATMENT OF THE PATIENT¿S INJURY HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Patient problems: Limb Fracture

    MAUDE report 24176626 ↗
  • InjuryDec 17, 2020Use of Device Problem; Use of Device Problem

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED FOLLOWING EXAMINATION ON THE MAGNETOM ESSENZA DOT SYSTEM. ONE PATIENT SHOWED SOME REDNESS ON THE RIGHT ARM DURING AN EXAMINATION. THE EXAMINATION WAS STOPPED AND THE PATIENT WAS REPOSITIONED. ANOTHER PATIENT COMPLAINED OF HEAT IN HIS WRIST DURING A WRIST EXAM. THE PROCEDURE WAS RE-STARTED AND SUCCESSFULLY COMPLETED. THE USER ALSO OBSERVED THAT MOST PATIENTS ARE SWEATING DURING THE MRI SCANS. THE REPORTED EVENTS OCCURRED IN (B)(6).

    Patient problems: Burn(s)

    MAUDE report 11029478 ↗

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Sources and updates

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