MAGNETOM ESSENZA 10836618Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056869006789), received between Sep 10, 2021 and Nov 8, 2022 — classified as 4 injuries.

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

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT WAS BURNED DURING AN MRI SHOULDER STUDY USING THE MAGNETOM ESSENZA DOT SYSTEM AND A FLEX 4 LARGE COIL. THE BURN SYMPTOMS WERE OBSERVED ON AN AREA OF SKIN ONE DAY AFTER THE SCAN. BASED ON THE INFORMATION OBTAINED BY SIEMENS SO FAR, THE PATIENT HAS SKIN DISEASE AND WORE A METAL ACCESSORY DURING THE SCAN NEAR THE SCAN AREA. THE BURN WAS OBSERVED IN THE AREA WHERE THE METAL ACCESSORY WAS WORN. THE DEGREE AND EXTENT OF THE BURN AREA AND THE NECESSITY OF MEDICAL INTERVENTION ARE UNKNOWN. SYSTEM MAINTENANCE INFORMATION PROVIDED BY THE ENGINEER REPORTED THE SYSTEM WAS NOT FAULTY AND NO ALLEGATION OF COMPLAINT AGAINST THE SYSTEM IS ALLEGED. THIS REPORT IS BEING SUBMITTED TO ADDRESS THE BURN INJURY SUSTAINED BY THE PATIENT. THE PATIENT BURN IS CONSIDERED A SERIOUS INJURY. THE REPORTED EVENT OCCURRED IN INDIA.

  Patient problems: Burn(s)

  MAUDE report 15751155 ↗
• InjurySep 14, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED A PATIENT UNDERWENT A MR EXAMINATION ON (B)(6) 2021, AND HAS SUFFERED PERSISTENT TINNITUS SINCE THEN. THE PATIENT DID NOT WEAR HEADPHONES OR EARPLUGS AND NO OTHER HEARING PROTECTION WAS PROVIDED. AS OF THE DATE OF THIS REPORT, ADDITIONAL INFORMATION FROM THE PATIENT IS BEING CLARIFIED. IT IS UNCLEAR IF THE TINNITUS IS TEMPORARY OR PERMANENT. THE REPORTED EVENT OCCURRED IN JAPAN.

  Patient problems: Hearing Impairment

  MAUDE report 15419272 ↗
• InjuryNov 29, 2021Break

  IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WITH A PATIENT WEARING COCHLEAR IMPLANTS DURING AN EXAMINATION ON THE MAGNETOM ESSENZA DOT UNIT. THE COCHLEAR IMPLANTS WERE DAMAGED DURING THE EXAMINATION. THIS RESULTED IN PATIENT NEEDING A SURGERY TO REPLACE THE IMPLANTS. NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Hearing Impairment

  MAUDE report 12883649 ↗
• InjurySep 10, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE PERFORMING MAINTENANCE ON THE MAGNETOM ESSENZA DOT SYSTEM. A SIEMENS SERVICE ENGINEER WAS INJURED WHEN AN ELECTRICAL CONNECTOR ON A POWER CABLE (MREF POWER CABLE) SPARKLED WHEN TURNING ON THE CIRCUIT BREAKER INSIDE THE COOLING CABINET DURING MAINTENANCE. THE SIEMENS SERVICE ENGINEER SUFFERED A FIRST DEGREE BURN TO THE RIGHT HAND. THE SKIN ON THE RIGHT HAND WAS SENSITIVE TO THE TOUCH AT THAT TIME BUT DID NOT REQUIRE ANY TREATMENT. ADDITIONALLY, IT WAS REPORTED THAT THE SIEMENS SERVICE ENGINEER WAS WEARING A HEARING AID AT THE TIME OF THE EVENT AND SUFFERED HEARING LOSS. IT IS NOT KNOWN IF THE HEARING LOSS IS PERMANENT AS THE SIEMENS SERVICE ENGINEER REPORTS TO STILL BE EXPERIENCING TINNITUS BUT HAS NOT YET VISITED A DOCTOR. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Superficial (First Degree) Burn; Tinnitus

  MAUDE report 12452318 ↗