MAGNETOM Aera 10432914Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04056869006697), received between Jul 24, 2020 and Aug 31, 2026 — classified as 22 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).

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

9 other recalls cover devices cleared under the same FDA submission (K111242, K132951, K133435, K140253, K141977, K142515, K153343, K163312, K173592, K182299, K190138, K191050, K202014, 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 18, 2026.

Recalls naming this device

1. 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  Patient problems: Bruise/Contusion

  MAUDE report 50518893 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  Patient problems: Limb Fracture

  MAUDE report 50518735 ↗
• InjuryMay 29, 2026Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY ASSOCIATED WITH A MAGNETOM AREA SYSTEM. IT WAS COMMUNICATED THAT THE PATIENT WAS BURNED. ALTHOUGH SIEMENS HEALTHINEERS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE NATURE AND EXTENT OF THE PATIENT¿S BURN INJURY, A RESPONSE HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 25332201 ↗
• InjuryNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ***CORRECTION OF SECOND SENTENCE*** SIEMENS HEALTHINEERS WAS NOTIFIED OF A POTENTIAL PATIENT INJURY INVOLVING THE MAGNETOM AERA SYSTEM. THE PATIENT WAS PROVIDED WITH EARPLUG HEARING PROTECTION DURING AN EXAMINATION FOR THE FULL DURATION OF THE EXAM. DURING THE FOLLOWING SCAN, THE PATIENT CLAIMED THAT THEY HAD DEVELOPED A TINNITUS IN BOTH EARS THAT WAS ONGOING AND NOT SUBSIDING

  Patient problems: Tinnitus

  MAUDE report 23568225 ↗
• MalfunctionNov 17, 2025Excessive Heating; Excessive Heating

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY INVOLVING THE MAGNETOM AERA SYSTEM BODY 18 COIL. IT WAS STATED THAT THE BODY 18 COIL BECAME HOT DURING THE EXAMINATION AND BURNED THE PATIENT BETWEEN THE THIGHS. ADDITIONAL INFORMATION ABOUT THE SEVERITY OF THE BURNS AND MEDICAL TREATMENT PROVIDED HAS BEEN REQUESTED BY SIEMENS HEALTHINEERS BUT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 23568211 ↗
• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A POTENTIAL PATIENT INJURY INVOLVING THE MAGNETOM AERA. PER THE INFORMATION RECEIVED FROM THE CUSTOMER IT WAS STATED THAT A PATIENT HAD BLISTERS IN THE AREA OF THE EXAMINATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED BY SIEMENS HEALTHINEERS REGARDING ADDITIONAL EVENT DETAILS, EXTENT OF THE PATIENT¿S INJURY, AND ANY MEDICAL TREATMENT THAT MAY HAVE BEEN PROVIDED. THE ADDITIONAL INFORMATION IS PENDING RECEIPT AS OF THE DATE OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 23310078 ↗
• InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY INVOLVING THE MAGNETOM AERA SYSTEM. PER THE RECEIVED INFORMATION, THE PATIENT RECEIVED A BURN ON HIS CHEEK FROM THE HEAD COIL USED DURING THE EXAMINATION. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE EVENT AND THE EXTENT OF THE PATIENT¿S INJURY. THE ADDITIONAL INFORMATION IS PENDING RECEIPT AS OF THE DATE OF THIS REPORT.

  Patient problems: Burn(s)

  MAUDE report 22976117 ↗
• MalfunctionJul 2, 2025Difficult to Advance; Difficult to Advance

  SIEMENS HEALTHINEERS WAS NOTIFIED THAT THE MAGNETOM AERA DOCKING STATION WAS DIFFICULT TO MOVE WHILE A PATIENT WAS ON THE TABLE. IT WAS STATED THAT THE MRI TECHNICIAN WAS INJURED DUE TO THIS ISSUE. ADDITIONAL INFORMATION REGARDING THE MRI TECHNICIAN¿S INJURY WAS REQUESTED FROM THE CUSTOMER. SINCE THE SEVERITY OF THE INJURY IS UNKNOWN, THIS EVENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22381866 ↗
• InjuryJun 30, 2025Excessive Heating; Excessive Heating

  SIEMENS HEALTHINEERS WAS NOTIFIED REGARDING A PATIENT INJURY POTENTIALLY ASSOCIATED WITH A MAGNETOM AERA BODY COIL. IT WAS STATED IN THE COMPLAINT THAT THE BODY COIL WAS HEATING UP. THERE WERE TWO AFFECTED PATIENTS. PATIENT 1 TOLD THE CUSTOMER THAT HE HAD A BURNING SENSATION AFTER AN MRI EXAMINATION ON (B)(6) 2024. SIX MONTHS LATER, THE CUSTOMER WAS NOTIFIED BY PATIENT 1 REGARDING THIS EXAMINATION STATING THAT A BLISTER HAS APPEARED. REPORTEDLY THE PHYSICIAN DIAGNOSED IT A SECOND-DEGREE BURN. PATIENT 2 UNDERWENT AN MRI EXAMINATION DURING (B)(6) 2025. PATIENT 2 REPORTED THAT HE HAD A BURNING SENSATION DURING THE EXAMINATION. PICTURES OF PATIENT 1 WERE PROVIDED TO OUR SIEMENS MEDICAL OFFICER. THE MEDICAL OFFICER COULD NOT EXCLUDE A GRADE 2B OR 3 BY MEANS OF THE PROVIDED IMAGES. THE PATIENT 1 BURN WAS DETERMINED TO BE A SERIOUS INJURY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22356787 ↗
• InjuryMay 14, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE COMPLAINT DESCRIPTION, A PATIENT INFORMED FDA ABOUT AN INJURY AFTER HER EXAMINATION THREE YEARS AGO. IN HER REPORT THE PATIENT STATED THE FOLLOWING: BOTH OF HER FEET WERE BURNED DURING AN MRI EXAMINATION OF HER LEFT FOOT. THE PATIENT'S FEET WERE PUT ON A PILLOWCASE AND NO ADDITIONAL PADDING WAS USED. DURING THE EXAMINATION HER FEET FELT WARM AND WHEN SHE INFORMED THE TECHNICIAN SHE WAS TOLD THAT THIS WAS NORMAL. AFTER THE EXAMINATION SHE HAD A SQUARE INDENTATION ON HER LEFT FOOT THE SIZE OF A NICKEL WITH A DEEP BURN. BOTH FEET SOLES AND HEELS WERE SEVERELY BURNED, AND SHE HAD BLISTERS OVER HER BELLY, BREAST AND UPPER LEGS. THE PATIENT HAD MULTIPLE SURGERIES, WAS UNABLE TO WALK FOR MONTHS DUE TO SWELLING AND PAIN AND STILL HAS PROBLEMS WITH SWELLING AND ABNORMAL SKIN AT HER FEET.

  Patient problems: Burn(s)

  MAUDE report 22017205 ↗
• InjuryJan 31, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED TO SIEMENS THAT A PATIENT ALLEGES THAT SHE UNDERWENT A BREAST MR EXAM ON (B)(6)2024 WHILE USING THE MAGNETOM AERA. PRIOR TO THE EXAM SHE WAS NOT OFFERED EAR PLUGS AND WAS GIVEN SOME HEADPHONES (UNKNOWN MANUFACTURER) WHICH ONLY PARTIALLY COVERED HER EARS. AFTER THE EXAM SHE EXPERIENCED RINGING IN THE EARS AND EAR PAIN. SHE ALLEGES THAT SHE HAS HAD PERSISTENT TINNITUS SINCE THE MR EXAM. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: Tinnitus

  MAUDE report 21281574 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIEMENS BECAME AWARE OF AN ADVERSE EVENT THAT OCCURRED WHILE OPERATING THE MAGNETOM AERA SYSTEM. WHILE BEING PREPARED FOR THE HEAD EPILEPSY SCAN ON THE MRI MACHINE, PRIOR TO CONTRAST BEING ADMINISTERED, THE PATIENT COMPLAINED ABOUT BLURRED VISION, HEADACHE, DIZZINESS, AND A HEATING SENSATION AROUND THE HEAD. ADDITIONAL INFORMATION WAS RECEIVED THAT A MEDICAL TEAM ATTENDED TO THE PATIENT. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM, HOWEVER, NO INFORMATION ABOUT MEDICAL TREATMENT WAS PROVIDED TO SIEMENS, AND THE PATIENT'S CURRENT HEALTH STATUS IS UNAVAILABLE AT THE MOMENT. SIEMENS REQUESTED ADDITIONAL INFORMATION TO CONDUCT AN INVESTIGATION OF THE REPORTED ISSUE.

  Patient problems: Blurred Vision; Headache

  MAUDE report 21034648 ↗
• InjuryMay 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT EVENT DURING AN MRI EXAMINATION USING THE MAGNETOM AERA SYSTEM. ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT REQUESTED THE EXAMINATION TO BE STOPPED DUE TO KNEE DISCOMFORT, PAIN, AND CALF-TWITCHING. THE SCAN WAS DISCONTINUED. THE PATIENT THEN COMPLAINED OF CONSTANT SHIN PAIN, PAIN AT THE BACK OF THE KNEE, AND ALTERED AMBULATION. THE PATIENT HAD PREVIOUSLY UNDERGONE MEDICAL TREATMENT TO REPAIR THE ANTERIOR CRUCIATE LIGAMENT (ACL) IN THE AFFECTED KNEE ON AN UNKNOWN DATE IN 2009. DURING THIS PROCEDURE TWO METAL IMPLANTS HAD BEEN INSERTED TO TREAT THE ACL. THE PATIENT HAD STATED THAT HE HAD MADE A FULL RECOVERY FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT STATED THAT HE HAD ONE OF THE TWO METAL FIXATION DEVICES REMOVED PRIOR TO THIS RECENT MRI EXAMINATION. IN A SEPARATE BUT SIMILAR INCIDENT DURING MAY 2020, SIEMENS HEALTHINEERS WAS NOTIFIED THAT THE PATIENT HAD UNDERGONE AN MRI SCAN OF HIS SHOULDER AND HAD EXPERIENCED VERY STRONG PERIPHERAL NERVE STIMULATION IN THE HANDS, FEET, AND ALONG THE SCAR OF THE PREVIOUS ACL REPAIR. FOLLOWING THE MRI EXAMINATION, THE PATIENT COMPLAINED OF ¿KNEE STIFFNESS ACCOMPANIED BY SEVERE PAIN IN THE SHIN

  Patient problems: Limb Pain

  MAUDE report 19257942 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ADVERSE PATIENT EVENT DURING AN MRI EXAMINATION ON THE MAGNETOM AERA SYSTEM. THE PATIENT REQUIRED A HEAD EXAMINATION TO DIAGNOSIS A POTENTIAL STROKE. WHEN THE TECHNICIANS PLACED THE PATIENT ON THE EXAMINATION TABLE, THEY GAVE HER THE ALARM BALL, BUT SHE DID NOT HAVE THE STRENGTH TO HOLD IT WITH HER HANDS. THE PATIENT WAS APHASIC AND THEREFORE, DID NOT UNDERSTAND WHAT THE TECHNICIANS WERE SAYING TO HER. A HEAD COIL WAS PLACED ON THE PATIENT¿S HEAD. DURING PATIENT POSITIONING, THE PATIENT DID NOT WANT TO LOWER HER LEGS ONTO THE EXAMINATION TABLE. THE TECHNICIANS DECIDED TO PERFORM THE MRI EXAMINATION WITH THE PATIENT¿S LEGS BENT. DURING THE SCANNING SEQUENCES, THE PATIENT MOVED HER HEAD A LOT BUT DID SO WITHOUT MOVING OTHER PARTS OF HER BODY. THE POSITIONING OF THE MRI SURVEILLANCE CAMERA DID NOT MAKE IT POSSIBLE TO DETECT THE PATIENT'S DISCOMFORT. TO IMPROVE THE SCANNING IMAGE QUALITY, ONE OF THE TWO TECHNICIANS, ENTERED THE EXAMINATION ROOM TO ASK THE PATIENT TO STOP MOVING. WHEN THE TECHNICIAN ARRIVED, IT WAS DISCOVERED THAT THE PATIENT HAD VOMITED ON THE EXAMINATION TABLE AND FLOOR AND MAY HAVE ASPIRATED THE VOMIT. THE TECHNICIAN QUICKLY EX

  Patient problems: Aspiration/Inhalation

  MAUDE report 18885681 ↗
• InjuryDec 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS HEALTHINESS WAS INFORMED THAT A PATIENT COMPLAINED OF TINNITUS AND HIGH-PITCHED NOISE ALONG WITH PROBLEMS SLEEPING AFTER AN MRI EXAMINATION. THE TINNITUS WAS STATED TO HAVE OCCURRED AFTER THE PATIENT¿S FIRST MRI LSPINE EXAMINATION ON OCTOBER 3, 2023 . DURING THIS EXAMINATION, THE PATIENT WAS WEARING HEADPHONES WITHOUT EAR PLUGS. FOR THE SECOND EXAMINATION (CSPINE) ON OCTOBER 13, 2023, THE PATIENT HAD BROUGHT THEIR OWN EAR PLUGS. SIEMENS HEALTHINEERS WAS INFORMED THAT THE PATIENT IS CURRENTLY BEING TREATED BY A PHYSICIAN FOR THE ISSUES; HOWEVER, NO INFORMATION HAS BEEN RECEIVED STATING WHETHER THE TINNITUS IS PERMANENT OR REVERSIBLE AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION, IF AVAILABLE, IS PENDING RECEIPT BY SIEMENS HEALTHINEERS.

  Patient problems: Tinnitus

  MAUDE report 18300029 ↗
• InjuryNov 22, 2023Excessive Heating; Excessive Heating

  SIEMENS HEALTHINEERS WAS INFORMED THAT TA PATIENT SUSTAINED A BURN ON THEIR HAND DURING A LUMBAR SPINE EXAMINATION. FURTHERMORE, SEVERAL PATIENTS COMPLAINED ABOUT A HEATING SENSATION DURING EXAMINATION. PER THE COMPLAINT REPORT SIEMENS IS UNAWARE OF A SERIOUS INJURY ASSOCIATED WITH THIS ISSUE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY SIEMENS REGARDING THE SEVERITY OF THE PATIENT'S INJURY OR THE OTHER PATIENTS WHO COMPLAINED OF A HEATING SENSATION.

  Patient problems: Burn(s)

  MAUDE report 18193645 ↗
• InjuryOct 11, 2023Adverse 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 AERA MR SYSTEM. A PATIENT UNDERWENT A FOOT AND ANKLE SCAN ON (B)(6), 2023. THE SCAN WAS PERFORMED WITH NO COMPLICATIONS. AFTER THE PATIENT RETURNED HOME, THE PATIENT'S SPOUSE CALLED THE CUSTOMER TO REPORT THAT THE PATIENT HAD BEEN SEVERELY BURNED ON THE OPPOSITE LEG. THE CUSTOMER EXPLAINED THAT THE PATIENT DID NOT MENTION ANY TYPE OF DISCOMFORT RELATED TO BURNING WHILE BEING SCANNED. THE CUSTOMER HAS ALSO STATED THAT THE PATIENT WAS DIABETIC AND WAS WEARING COMPRESSION SOCKS. THE CUSTOMER MENTIONED MORE IMPORTANTLY THAT THE BURN WAS ON THE LEG THAT WAS NOT IN THE MR COIL. ACCORDING TO INFORMATION RECEIVED AND A PICTURE OF THE INJURY, THE PATIENT SUSTAINED A BURN ON HIS LEG WITH REDNESS AND A LARGE BLISTER UNDER THE MEDICAL GRADE COMPRESSION STOCKINGS HE WAS WEARING. OUR CMO HAS ASSESSED THIS BURN AS A 2ND OR 3RD DEGREE BURN. THE PATIENT DID NOT NOTICE THE INJURY UNTIL HE TOOK OFF THE SOCK AT HOME. THE PATIENT CONSULTED A WOUND CARE NURSE THE SAME DAY WHO ADVISED HIM TO GO TO THE ER. NO FURTHER INFORMATION REGARDING MEDICAL TREATMENT OR MEDICAL INTERVENTION HAS BEEN PROVIDED. SIEMENS HAS REQUESTED

  Patient problems: Burn(s)

  MAUDE report 17911061 ↗
• InjuryAug 4, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  SIEMENS HEALTHINEERS WAS INITIALLY INFORMED BY THE YAMANASHI PREFECTURAL POLICE THAT A PATIENT COMPLAINED TO THEM THAT THEY SUFFERED BURNS ON THEIR BACK. THE DATE OF THE EVENT WAS INITIALLY REPORTED AS 2023-07-21. THE POLICE WERE INQUIRING ABOUT THE EVENT WITH SIEMENS HEALTHINEERS. THE SEVERITY OF THE PATIENT¿S BURNS WAS NOT SPECIFIED BY THE POLICE DURING THE INITIAL INQUIRY. ADDITIONAL INFORMATION RECEIVED BY SIEMENS HEALTHINEERS ON 2023-08-02 REVEALED THE PATIENT INCIDENT OCCURRED ON AN UNKNOWN DAY DURING (B)(6) 2020. IT WAS FURTHER CLARIFIED THAT THE CUSTOMER FACILITY DID NOT CONTACT THE LOCAL SIEMENS CUSTOMER SERVICE ORGANIZATION AT THE TIME OF THE INCIDENT. AT THIS TIME, ADDITIONAL INFORMATION REGARDING THE SEVERITY OF THE INJURY, MEDICAL INTERVENTION, CURRENT PATIENT STATUS, HAVE BEEN REQUESTED. AS THE DATE OF THIS REPORT, SIEMENS CANNOT EXCLUDE WITH ABSOLUTE CERTAINTY THAT A SERIOUS INJURY OCCURRED.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 17465633 ↗
• InjuryMay 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT ON (B)(6) 2023, A RATHER TALL PATIENT (APPROX. 6 FEET) WAS LYING IN A PRONE POSITION FOR AN ELBOW EXAMINATION. IT WAS STATED THAT HIS FEET WERE APPARENTLY AT THE VERY END OF THE TABLETOP, WHICH MOVES THE PATIENT IN AND OUT OF THE BORE. HIS ANKLES RESTED ON A CUSHION FOR COMFORT AND SUPPORT. ON COMPLETION OF THE EXAM THE PATIENT WAS REMOVED FROM THE SCANNER. THE PATIENT CLAIMS THAT THEY HIT THEIR FEET INTO THE HANDLE AT THE END OF THE PATIENT TABLE WHEN THEY WERE MOVED OUT OF THE BORE. THE PATIENT FURTHER CLAIMS THAT HIS BACK WAS JOLTED AND CAUSING HIM SIGNIFICANT PAIN AND ISSUES SINCE. AT THE TIME OF THIS INCIDENT THE PATIENT DID NOT SAY ANYTHING TO THE HOSPITAL STAFF. THE STAFF ALSO DID NOT WITNESS THAT THE PATIENT'S FEET ALLEGEDLY HIT THE HANDLE OF THE PATIENT TABLE. ONLY SOME TIME AFTERWARDS THE PATIENT RAISED A COMPLAINT. AS PER THE ADDITIONAL INFORMATION RECEIVED ON MAY 4, 2023, IT WAS CLARIFIED THAT NO MEDICAL INVENTION WAS NEEDED AT THE TIME, ALTHOUGH THE PATIENT CLAIMED THAT HE HAD TO SEEK MEDICAL ATTENTION FOR THEIR BACK. SIEMENS IS NOT AWARE OF THE SEVERITY OF THE INJURY AND THE POSSIBLE HEALTH CONSEQUENCES (BACK PAIN) FOR THE

  Patient problems: Pain

  MAUDE report 16931796 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION: SIEMENS WAS LATER INFORMED THAT THE INJURED COMPANION DIED ON (B)(6) 2023, BECAUSE OF THIS INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16223620 ↗
• InjuryApr 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM AREA MR SYSTEM. THE USER REPORTED THAT THE PATIENT TABLE DID NOT DOCK ONTO THE MR SYSTEM WHILE A HEAVY PATIENT WAS ON THE PATIENT TABLE. THE RADIOGRAPHER ASSUMED THAT THE PATIENT TABLE WAS NOT IN HOME POSITION AND PULLED THE TABLETOP TO BRING IT TO THE HOME POSITION. WHILE PULLING THE TABLETOP, THE RADIOGRAPHER INJURED THEIR SHOULDER. THE RADIOGRAPHER IS UNDER TREATMENT BY A PHYSIO AND GENERAL PRACTITIONER AS THEIR SYMPTOMS WORSENED OVER THE FIRST MONTH. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 14249185 ↗
• InjuryDec 15, 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 FOLLOWING A PROCEDURE ON THE MAGNETOM AERA SYSTEM. A PATIENT REPORTED SUFFERING SEVERAL BLISTERS ON THE FINGERS WHICH SPREAD TO THE ENTIRE HAND. THE PATIENT WAS EVALUATED BY TWO PHYSICIANS AND RECEIVED CONFLICTING DIAGNOSIS. THE PATIENT IS CURRENTLY UNDER THE CARE OF A PHYSICIAN. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Blister

  MAUDE report 13010505 ↗
• InjuryAug 21, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM AERA SYSTEM. THE USER REPORTED THAT A FEMALE PATIENT SUFFERED SECOND DEGREE BURNS ON BOTH THIGHS FOLLOWING EXAMINATION. THE PATIENT PRESENTED WITH REDNESS AND BLISTERS APPROXIMATELY 3 CM IN DIAMETER. THE PATIENT WAS PROVIDED WITH MEDICAL CARE. NO FURTHER INFORMATION REGARDING THE TYPE OF TREATMENT WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn; Patient Problem/Medical Problem

  MAUDE report 10437310 ↗
• InjuryAug 6, 2020Use of Device Problem; Human-Device Interface Problem; Inadequate User Interface; Use of Device Problem; Human-Device Interface Problem; Inadequate User Interface

  ACCORDING TO THE INFORMATION PROVIDED TO SIEMENS HEALTHINEERS BY THE HOSPITAL, A PATIENT WAS INJURED DURING A SCAN INVOLVING SIEMENS HEALTHINEERS MAGNETOM AERA DEVICE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10376365 ↗
• MalfunctionJul 24, 2020Poor Quality Image; Use of Device Problem; Poor Quality Image; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT THE MAGNETOM AERA SYSTEM DOES NOT PRODUCE GOOD QUALITY IMAGES. A RELAPSE OF A BREAST TUMOR WAS NOT CAPTURED DURING AN MRI EXAM USING THE 4-CHANNEL BREAST COIL. THE PATIENT HAD TO UNDERGO A SURGERY. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: Breast Cancer; Patient Problem/Medical Problem

  MAUDE report 10320362 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111242, K132951, K133435, K140253, K141977, K142515, K153343, K163312, K173592, K182299, K190138, K191050, K202014, K231560. One submission often covers many models, so check the product and lot details in each record.

• Z-2658-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Lumina (DE). Model Number: 11344916.
• 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.
• 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-2659-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Prisma. Model Number: 10849582.
• Z-2661-2025 · Aug 28, 2025 · Open, Classified
  MAGNETOM Skyra fit. Model Number: 10849580.
• Z-2343-2019 · Jul 9, 2019 · Terminated
  MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
• Z-2342-2019 · Jul 9, 2019 · Terminated
  MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
• Z-0467-2016 · Dec 7, 2015 · Terminated
  MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
• Z-1663-2014 · Apr 24, 2014 · Terminated
  MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional