MAGNETOM SempraRecalls & reported problems across all models
Siemens Shenzhen Magnetic Resonance Ltd. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MAGNETOM Sempra model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of MAGNETOM Sempra by Siemens Shenzhen Magnetic Resonance Ltd. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2021 and Oct 9, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MAGNETOM Sempra recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 1, 2023Open, Classified
In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used
Z-2648-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported MAGNETOM Sempra problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- Bone Fracture(s)1
- Unspecified Respiratory Problem1
MAGNETOM Sempra models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAGNETOM Sempra 10840815System, nuclear magnetic resonance spectroscopic1 recall1 report
- MAGNETOM Sempra 10840816System, nuclear magnetic resonance imaging1 report
Recent MAGNETOM Sempra adverse event reports
The 2 most recent reports across all models, 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 ↗MalfunctionOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM SEMPRA SYSTEM. DURING A PELVIS SCAN, A (B)(6) YEAR OLD FEMALE PATIENT HAD DIFFICULTY BREATHING. THE PATIENT ALERTED THE OPERATOR AND THE SCAN WAS STOPPED. THE PATIENT WAS PROVIDED OXYGEN BUT WAS STILL HAVING DIFFICULTY BREATHING AND COLLAPSED AND BECAME UNCONSCIOUS. THE PATIENT WAS TRANSFERRED TO THE CARDIAC ICU FOR FURTHER MANAGEMENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.
Patient problems: Unspecified Respiratory Problem
MAUDE report 12613760 ↗
Other Siemens Shenzhen Magnetic Resonance Ltd. products
All Siemens Shenzhen Magnetic Resonance Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page