MAGNETOM PrismaRecalls & reported problems across all models

We found 2 models of MAGNETOM Prisma by Siemens Healthcare GmbH in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, 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).

2 FDA recall records name at least one of these models by its device 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. 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

MAGNETOM Prisma 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.

1. Aug 28, 2025Open, 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-2659-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported MAGNETOM Prisma problems

MAGNETOM Prisma models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MAGNETOM Prisma 10849582

  System, nuclear magnetic resonance imaging
  2 recalls0 reports
• MAGNETOM Prisma 10849583

  System, nuclear magnetic resonance imaging
  1 recall2 reports

Recent MAGNETOM Prisma adverse event reports

The 2 most recent reports across all models, 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 ↗

Other Siemens Healthcare GmbH products

• Artis zeego2 models · 31 reports · 6 recalls
• MAGNETOM Verio2 models · 2 reports · 4 recalls
• MAGNETOM Skyra2 models · 10 reports · 3 recalls
• MAGNETOM Cima.X2 models · 0 reports · 3 recalls
• MAGNETOM Vida2 models · 12 reports · 2 recalls
• MAGNETOM Lumina2 models · 3 reports · 2 recalls
• MAGNETOM Sola2 models · 16 reports · 1 recall
• Cios Alpha2 models · 15 reports · 1 recall