MAGNETOM Sempra 10840816Recalls & reported problems
Siemens Shenzhen Magnetic Resonance Ltd. · MRI Scanner · Class 2
All models of MAGNETOM Sempra (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 04056869044538), received between Oct 9, 2023 and Oct 9, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device 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
- Use of Device Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM SEMPRA MR SYSTEM. ON (B)(6) 2023, A CART WAS TAKEN INTO THE MAGNETOM SEMPRA MAGNET ROOM AND WAS ATTRACTED TO THE MAGNET DURING A PATIENT PROCEDURE. THE PATIENT SUSTAINED FOUR (4) RIB FRACTURES AND A FACIAL BONE FRACTURE. THE PATIENT IS CURRENTLY STABLE. IT WAS CONFIRMED BY A SIEMENS SERVICE ENGINEER THAT THERE IS NO SYSTEM MALFUNCTION AND SPECIAL WARNING SIGNS ARE POSTED AT THE ENTRANCE OF THE CONTROLLED ACCESS AREA (MAGNET ROOM). SIEMENS IS AWAITING ADDITIONAL INFORMATION WITH RESPECT TO THE PATIENT¿S INJURIES AND PROVIDED MEDICAL INTERVENTION. SIEMENS IS ALSO AWAITING ADDITIONAL DETAILS OF THE EVENT TO ASCERTAIN WHY THE METAL CART WAS BROUGHT INTO THE MAGNET ROOM.
Patient problems: Bone Fracture(s)
MAUDE report 17894023 ↗
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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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