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
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
- 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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