Artis one 10848600Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04056869009964), received between Sep 15, 2020 and Nov 20, 2025 — classified as 1 death, 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 21, 2023Open, Classified

   Examination room monitor connected with the hybrid cable may have a display issue and no image function is available

   Z-1469-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Radiation Overexposure; Radiation Overexposure

  SIEMENS WAS INFORMED ABOUT POTENTIAL RADIATION OVEREXPOSURE ON THE ARTIS ONE SYSTEM. ON (B)(6) 2025, A PATIENT UNDERWENT A CEREBRAL ANEURYSM EMBOLIZATION PROCEDURE. ON (B)(6) 2025, THE PATIENT RETURNED TO HOSPITAL AND REPORTED TO HAVE EXPERIENCED HAIR LOSS SUBSEQUENT TO THE PROCEDURE. THE CUSTOMER REQUESTED TO CHECK THE RADIATION DOSE DELIVERED ON THE DAY OF THE INVOLVED PROCEDURE. THE SYSTEM IS BEING TESTED BY A SIEMENS LOCAL SERVICE TEAM. SIEMENS REQUESTED ADDITIONAL INFORMATION ABOUT THIS EVENT.

  Patient problems: Hair Loss

  MAUDE report 23605505 ↗
• MalfunctionSep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. THE SYSTEM WOULD NOT START UP PRIOR TO THE BEGINNING OF AN UNPLANNED EMERGENCY PATIENT PROCEDURE. THE PATIENT WAS RELOCATED TO A DIFFERENT MEDICAL FACILITY TO COMPLETE THE PROCEDURE. WE ARE UNAWARE OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23061931 ↗
• MalfunctionFeb 20, 2025Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. PRIOR TO AN EMERGENCY PATIENT PROCEDURE, IT WAS DISCOVERED THAT SYSTEM MOVEMENTS WERE BLOCKED. THE PATIENT WAS RELOCATED TO A DIFFERENT MEDICAL FACILITY TO COMPLETE THE PROCEDURE ON AN ALTERNATE UNIT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424060 ↗
• MalfunctionJan 23, 2025Radiation Output Problem; Radiation Output Failure; Radiation Output Problem; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE USING THE ARTIS ONE. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THE SMALL FOCUS OF THE DEVICE DID NOT EMIT RADIATION AND THE X-RAY WAS ABORTED. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216393 ↗
• MalfunctionDec 2, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT IMAGES WERE DARK, AND X-RAY WAS ABORTED. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817417 ↗
• MalfunctionJul 2, 2024Poor Quality Image; Mechanical Jam; Poor Quality Image; Mechanical Jam

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING AN INTERVENTIONAL NEUROLOGY TREATMENT FOR SUBARACHNOID HEMORRHAGE, THE SYSTEM C-ARM STAND MOVEMENTS WERE BLOCKED, AND THE MACHINE ACTIVATED COLLISION PROTECTION. THE DEVICE DISPLAYED IMAGING ERRORS ON THE MONITOR, AND THE IMAGE WAS BLURRY. DUE TO LOW IMAGE QUALITY, IT WAS NOT POSSIBLE FOR THE USER TO PERFORM THE PROCEDURE; AND THE SEDATED PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY TO COMPLETE THE PROCEDURE. THE TREATMENT WAS SUCCESSFULLY COMPLETED ON AN ALTERNATE UNIT. THERE ARE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656327 ↗
• MalfunctionApr 23, 2024Output Problem; Output Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. SMALL FOCUS X-RAY IMAGING WAS NOT POSSIBLE DURING AN EMERGENCY CARDIOLOGY PROCEDURE. PATIENT WAS RELOCATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON AN ALTERNATE UNIT. SIEMENS IS UNAWARE OF ANY HEALTH CONSEQUENCES TO THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164465 ↗
• MalfunctionApr 19, 2024No Display/Image; Output Problem; No Display/Image; Output Problem

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. AN 82-YEAR-OLD PATIENT IN CARDIOGENIC SHOCK UNDERGOING RESUSCITATION IN THE AMBULANCE ARRIVED AT THE MEDICAL FACILITY. THE PATIENT WAS TAKEN DIRECTLY TO THE CATH LAB AND PLACED ON THE TABLE OF THE ARTIS ONE UNIT. THE MONITOR IN THE EXAMINATION ROOM DID NOT DISPLAY PATIENT IMAGES. THE PATIENT IMAGES WERE DISPLAYED NORMALLY IN THE CONTROL ROOM. THE USER POWERED THE UNIT OFF AND ON BUT THE IMAGE ISSUE IN THE EXAMINATION ROOM REMAINED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE USER TRIED TO MOVE THE CONTROL ROOM MONITOR TO THE EXAMINATION ROOM TO START THE PROCEDURE, HOWEVER, FOR AN UNKNOWN REASON IT WAS UNSUCCESSFUL. THE MEDICAL FACILITY DID NOT HAVE AN ALTERNATE IMAGING SYSTEM, AND THE USER ATTEMPTED TO MOVE THE PATIENT TO A DIFFERENT CLINIC. HOWEVER, THE PATIENT SHOWED RAPID DETERIORATION AND WAS NO LONGER TRANSPORTABLE. THE PATIENT PASSED AWAY. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION ABOUT THIS EVENT.

  Patient problems: Cardiogenic Shock

  MAUDE report 19144976 ↗
• MalfunctionDec 26, 2023Radiation Output Failure; Activation Problem; Radiation Output Failure; Activation Problem

  SIEMENS HEALTHINEERS WAS INFORMED BY ITS SERVICE ORGANIZATION REGARDING A MALFUNCTION ASSOCIATED WITH THE ARTIS ONE SYSTEM. IT WAS STATED THAT NO X-RAY WAS POSSIBLE DURING AN EMERGENCY PROCEDURE. THE PATIENT WAS RELOCATED TO ANOTHER SYSTEM FOR COMPLETION OF THE PROCEDURE. NO ADVERSE HEALTH CONSEQUENCE TO THE PATIENT WAS COMMUNICATED TO SIEMENS HEALTHINEERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392652 ↗
• MalfunctionNov 3, 2023Loss of Power; Loss of Power

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, NO SYSTEM MOVEMENTS WERE AVAIBLE TO THE USER. THE PATIENT HAD TO BE RELOCATED TO A DIFFERENT MEDICAL FACILITY TO COMPLETE THE PROCEDURE ON AN ALTERNATE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065132 ↗
• MalfunctionAug 15, 2022Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE PC FROZE, AND THE SYSTEM WENT INTO THE BYPASS MODE. THE USER SWITCHED OFF THE SYSTEM AND THE POWER SUPPLY DISTRIBUTOR AND TRIED REBOOTING THE UNIT. HOWEVER, WAS UNABLE TO RESTART THE DEVICE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.THE REPORTED EVENT OCCURRED IN CHINA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225471 ↗
• MalfunctionMay 16, 2022Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, NO X-RAY WAS AVAILABLE. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED ON AN ALTERNATE UNIT. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407622 ↗
• InjuryJan 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. AT THE BEGINNING OF A PROCEDURE, A COVER FROM THE DISPLAY CEILING SUSPENSION SYSTEM FELL AND HIT THE PATIENT. THE PROCEDURE WAS CONTINUED AND COMPLETED. FOLLOWING THE PROCEDURE, THE PATIENT WAS OBSERVED BY THE NURSING TEAM AND DID NOT PRESENT ANY COMPLICATIONS. AFTER OBSERVATION, THE PATIENT WAS RELEASED ON THE SAME DAY. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13332638 ↗
• MalfunctionDec 13, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE SYSTEM WENT INTO BYPASS MODE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982565 ↗
• DeathNov 11, 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 WHILE OPERATING THE ARTIS ONE SYSTEM. THE USER REPORTED THAT A FIRE OCCURRED ON THE SYSTEM TABLE DURING PATIENT TREATMENT. THE USER ALSO REPORTED THAT THE FIRE WAS NOT DUE TO A SYSTEM FAILURE. IT WAS LATER REPORTED THAT THE PATIENT PASSED AWAY. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12793609 ↗
• MalfunctionSep 7, 2021Structural Problem; Structural Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WITH THE ARTIS ONE SYSTEM. IT WAS REPORTED THAT PART OF THE CEILING CONNECTED TO THE DCS PEELED OFF FROM ITS INNER BASE AND THE ENTIRE DCS MOUNTING FELL TO THE FLOOR. THE INCIDENT OCCURRED AT NIGHT AND NO ONE WAS IN THE ROOM. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432551 ↗
• MalfunctionAug 16, 2021No Display/Image; No Display/Image

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE ER MONITOR HAD A BLACK SCREEN. AFTER A SYSTEM RESTART, THE SYSTEM WENT INTO BYPASS MODE AND THE POWER OFF/ON WAS NOT ABLE TO RECOVER THE SYSTEM. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12323669 ↗
• MalfunctionAug 16, 2021No Display/Image; No Display/Image

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE ER MONITOR HAD A BLACK SCREEN. THE USER SWITCHED THE SYSTEM OFF/ ON THREE TIMES, HOWEVER, THE ER MONITOR ONLY DISPLAYED BYPASS MODE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12323667 ↗
• MalfunctionSep 15, 2020Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING A CARDIOLOGY PROCEDURE, THE USER REPORTED THAT THE MONITOR DISPLAY IN THE EXAM ROOM STARTED TO BLINK (IMAGE APPEARING AND DISAPPEARING). THE USER RESTARTED THE SYSTEM ,BUT COULDN'T FIX THE PROBLEM. THE PATIENT WAS TRANSFERRED TO ANOTHER SYSTEM IN THE SAME HOSPITAL, AND FINISHED THE PROCEDURE SUCCESSFULLY. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10534046 ↗