MAGNETOM Prisma 10849583Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869006734), received between Sep 7, 2021 and Apr 5, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K153343, K173592, K231560); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. 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 problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED FOLLOWING EXAMINATION ON THE MAGNETOM PRISMA FIT MR SYSTEM. THE PATIENT SUFFERED BURNS DURING AN EXAMINATION OF THE LUMBAR SPINE AND THE BILATERAL EXAMINATION OF THE HIP. THE TOTAL TIME EXAMINATION WAS APPROXIMATELY 1 HOUR AND 40 MIN. A WHITE INJURY WITH RED EDGES WITH AN ESTIMATED SIZE OF ABOUT 15CM IN DIAMETER ON BOTH SIDES OF THE PATIENTS FOREARMS WAS NOTICED IMMEDIATELY AFTER THE EXAMINATION. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Burn(s)

  MAUDE report 14012247 ↗
• InjurySep 7, 2021Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE PERFORMING MAINTENANCE ON THE MAGNETOM PRISMA FIT SYSTEM. IT WAS STATED THAT THE MAGNET QUENCHED UNEXPECTEDLY WHILE THREE CUSTOMER SERVICE ENGINEERS (CSE) PREPARED FOR RAMPING DOWN OF THE MAGNET. WHEN THE MAGNET QUENCHED, ALL CSES EXITED THE EXAMINATION ROOM IMMEDIATELY AND CLOSED THE DOOR BEHIND THEM. THE CSES CONTINUED WORKING. IN THE AFTERNOON, WHEN TWO OF THE CSES REFILLED THE MAGNET WITH LIQUID HELIUM, THE TWO CSES STARTED TO NOTICE A DETERIORATION OF THEIR HEALTH. THEY COMPLAINED ABOUT JOINT PAINS, SWEATING AND DIGESTION PROBLEMS. BECAUSE THEIR HEALTH PROBLEMS PERSISTED, THE CSES WENT TO A HOSPITAL THE NEXT DAY TO BE MEDICALLY CHECKED. IT WAS FOUND THAT THEIR OXYGEN SATURATION WAS VERY LOW. THEREFORE, THE CSES WERE PUT ON OXYGEN FOR 6 HOURS AND WERE PUT ON SICK LEAVE. THE TWO CSES CONTINUED TO UNDERGO VARIOUS EXAMS, HOWEVER, THE SEVERITY OF THEIR INJURIES COULD NOT YET BE DETERMINED WITH ABSOLUTE CERTAINTY. THE TWO CSES CONTINUE TO BE UNDER MEDICAL SUPERVISION AND ARE CURRENTLY STILL ON SICK LEAVE. WE THEREFORE PERFORM AN IN-DOUBT REPORTING.

  Patient problems: Discomfort; Fatigue

  MAUDE report 12433711 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153343, K173592, K231560. One submission often covers many models, so check the product and lot details in each record.

• Z-2659-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Prisma. Model Number: 10849582.
• Z-2658-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Lumina (DE). Model Number: 11344916.
• Z-2661-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Skyra fit. Model Number: 10849580.
• Z-2667-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
• Z-2660-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.