MAGNETOM Lumina 11344916Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056869230740), received between Jun 9, 2022 and Aug 14, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

2 FDA recall records name this device's identifier, 2 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, 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.

Recalls naming this device

1. Aug 28, 2025Class IOpen, Classified

   There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

   Z-2658-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Sep 1, 2023Class IIOpen, 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 problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2023Use of Device Problem; Use of Device Problem

  THE RISK MANAGER INFORMED SIEMENS HEALTHINEERS THAT TWO TECHNICIANS WERE INJURED WHEN THE MAGNETIC IV POLE WAS ATTRACTED BY THE MAGNET. ONE TECHNICIAN WAS STRUCK IN THE HEAD, BUT THE INJURY WAS VERY MINOR AND DID NOT REQUIRE MEDICAL TREATMENT. THE OTHER TECHNICIAN WAS STRUCK IN THE HAND, AND THE INJURY REQUIRED SURGICAL TREATMENT. SIEMENS WAS INFORMED THAT BOTH TECHNICIANS HAVE FULLY RECOVERED AND BACK TO WORK. ADDITIONALLY, IT WAS STATED BY THE RISK MANAGER, THAT ONE TECHNICIAN WAS AN MRI TECH, AND THE OTHER WAS A STAFF TECHNICIAN (NOT MRI). THE HOSPITAL HAS IMPLEMENTED ADDITIONAL MEASURES TO PREVENT ANOTHER OCCURRENCE OF FERROMAGNETIC MATERIAL BEING ATTRACTED BY THE MAGNET.

  Patient problems: Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 17546159 ↗
• InjuryAug 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JUNE 28TH, 2023, SIEMENS HEALTHINEERS WAS INFORMED ABOUT A POSSIBLE INJURY THAT OCCURRED DURING AN EXAMINATION WITH A SIEMENS MRI SYSTEM. IT WAS STATED THAT A PERSON CALLED THE MEDICAL CENTER (CUSTOMER FACILITY) STATING THAT AFTER AN MRI HIS EYES ARE ¿STRANGE", AND HE IS HAVING DIFFICULTY SEEING. THE ¿PATIENT" STATED HE LOOKED TO THE LASER WHEN HE WAS BEING POSITIONED FOR A LUMBAR SCAN. THE CUSTOMER FACILITY MEDICAL TECHNICIAN STATED IT IS UNLIKELY THAT A PATIENT¿S EYES WOULD BE EXPOSED TO THE LASER FOR A LUMBAR SCAN. DESPITE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION BY THE CUSTOMER FACILITY, THE ¿PATIENT¿ REFUSED TO SAY MORE. THE CUSTOMER FACILITY DID NOT KNOW THE NAME OR PATIENT NUMBER OF THE ¿PATIENT¿ NOR IN WHICH MRI THE EXAM WAS PERFORMED. THE MEDICAL CENTER HAS ANOTHER MRI BUT CHOOSE TO OPEN A NOTIFICATION FOR THIS SYSTEM WITH SIEMENS. ALTHOUGH REQUESTED BY SIEMENS HEALTHINEERS, ADDITIONAL INFORMATION FROM THE CUSTOMER FACILITY HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. FURTHERMORE, THERE IS NO EVIDENCE THAT THIS EXAMINATION HAS BEEN PERFORMED AT THE CUSTOMER¿S FACILITY AND THE ¿INJURY¿ WAS NOT CONFIRMED BY A PHYSICIAN. THIS EVENT WAS REPORTED DUE TO THE

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 17452126 ↗
• InjuryJun 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO SIEMENS THAT AFTER THE MR EXAMINATION, THE PATIENT'S LEFT ARM WAS BROKEN DURING HORIZONAL TABLE MOVEMENT. THE PATIENT WAS IMMEDIATELY ADMITTED BY THE EMERGENCY TEAM. IT WAS CONFIRMED THAT THE LEFT HUMERUS WAS BROKEN. THE PATIENT IS NOW AT HOME. SIEMENS HAS NOT RECEIVED ANY INFORMATION FROM THE CUSTOMER AS TO WHETHER THE FRACTURE HAD TO BE TREATED CONSERVATIVELY (IMMOBILIZATION BY A PLASTER CAST, SPLINT, SUPPORT BANDAGE) OR SURGICALLY TREATED. THIS REPORT HAS BEEN SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Limb Fracture

  MAUDE report 14642166 ↗