Artis zee floor 10094135Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 04056869010045), received between Jun 10, 2020 and May 28, 2026 — classified as 2 deaths, 1 injury, 91 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (18 reports).

3 FDA recall records name this device's identifier, 3 still open.

68 other recalls cover devices cleared under the same FDA submission (K122644, K141574, K181407); 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. Mar 21, 2024Class IIOpen, Classified

   Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

   Z-1598-2024 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 16, 2022Class IIOpen, Classified

   In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

   Z-1040-2023 · Root cause: Software design · Recall details · FDA record ↗

3. Feb 23, 2022Class IIOpen, Classified

   If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".

   Z-0967-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Radiation Overexposure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. THE USER REPORTED AN INCREASE IN RADIATION DOSE COMPARED TO PREVIOUS EXAMS. THE SYSTEM ALSO DISPLAYED A MESSAGE INDICATING THAT A POSSIBLE WRONG DOSE WAS APPLIED. NO ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317374 ↗
• MalfunctionFeb 11, 2026Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR UNIT. DURING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY COULD BE RELEASED BY THE OPERATOR WHILE USING THE FOOT SWITCH. THE PATIENT WAS RELOCATED TO A DIFFERENT MEDICAL FACILITY FOR FURTHER MEDICAL TREATMENT. 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 24312636 ↗
• MalfunctionNov 10, 2025Component Misassembled; Component Misassembled

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. IT WAS REPORTED THAT THE X-RAY WAS RELEASED WITHOUT AN OPERATOR GIVING A COMMAND OR INITIATING ACTIVATION. 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 23509375 ↗
• MalfunctionJul 15, 2025Positioning Problem; Positioning Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED BY ITS SERVICE ORGANIZATION OF AN ISSUE WITH THE ARTIS ZEE FLOOR SYSTEM STATING THAT STAND MOVEMENT WAS NOT POSSIBLE. ADDITIONAL INFORMATION WAS PROVIDED COMMUNICATING THAT THE FAILURE OCCURRED DURING AN EMERGENCY PROCEDURE, AND THE PATIENT WAS RELOCATED TO ANOTHER HOSPITAL FOR FURTHER MEDICAL TREATMENT. THERE ARE NO INDICATIONS OF ANY ADVERSE EFFECTS TO THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505772 ↗
• MalfunctionJun 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR UNIT. NO X-RAY EXPOSURE AND SYSTEM MOVEMENTS WERE AVAILABLE DURING A PROCEDURE. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ON-GOING; THEREFORE, THE EVENT IS REPORTED IN DOUBT.

  Patient problems: Insufficient Information

  MAUDE report 22158853 ↗
• MalfunctionFeb 24, 2025No Display/Image; Insufficient Device Problem Information; Radiation Output Failure; No Display/Image; Insufficient Device Problem Information; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE X-RAY FUNCTIONALITY WAS BLOCKED, AND THE RECEIVED IMAGES WERE DARK. THE PATIENT WAS RELOCATED 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446868 ↗
• MalfunctionDec 13, 2024Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED TO SIEMENS THAT AN ERROR OCCURRED WHILE USING THE ARTIS ZEE FLOOR. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THE SYSTEM SWITCHED OFF AND COULD NOT BE POWERED BACK ON. 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: Insufficient Information

  MAUDE report 20924506 ↗
• MalfunctionOct 28, 2024Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT X-RAY RELEASE WAS NOT POSSIBLE. 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 20543064 ↗
• MalfunctionOct 14, 2024Mechanical Jam; Output Problem; Radiation Output Failure; Mechanical Jam; Output Problem; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT STAND MOVEMENT WAS NOT POSSIBLE. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438045 ↗
• MalfunctionMay 29, 2024Radiation Output Failure; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR UNIT. DURING AN INTERVENTIONAL PROCEDURE FOLLOWING THE HEART VALVE REPLACEMENT, NO X-RAY COULD BE RELEASED BY THE USER. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING; THEREFORE, THE EVENT IS REPORTED IN DOUBT. 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 19414805 ↗
• MalfunctionApr 9, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR UNIT. DURING MOVEMENT OF THE DCS (DISPLAY CEILING SUSPENSION), THE COUNTERWEIGHT FELL DOWN AND HIT THE OPERATOR. HEALTH STATUS OF THE OPERATOR IS CURRENTLY UNKNOWN. SIEMENS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 19071637 ↗
• MalfunctionApr 2, 2024Poor Quality Image; Poor Quality Image

  SIEMENS BECAME AWARE OF A MALFUNCTION WHILE OPERATING THE ARTIS ZEE FLOOR UNIT. DURING AN EMERGENCY PROCEDURE, NO FLUORO WAS POSSIBLE, WHICH RESULTED IN BAD IMAGE QUALITY. THE PATIENT HAD TO BE MOVED AND THE PROCEDURE WAS COMPLETED ON AN ALTERNATE SYSTEM. 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 19018487 ↗
• MalfunctionMar 19, 2024Circuit Failure; Radiation Output Failure; Circuit Failure; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR UNIT. DURING AN INTERVENTIONAL PROCEDURE FOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI), NO X-RAY EXPOSURE WAS AVAILABLE. THE PATIENT HAD TO BE MOVED AND THE PROCEDURE WAS COMPLETED 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 18932911 ↗
• MalfunctionJan 25, 2024Radiation Overexposure; Radiation Overexposure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED ON THE ARTIS ZEE FLOOR UNIT. A POTENTIALLY HIGH DOSE READING FOR A PATIENT WAS COMMUNICATED. HOWEVER, DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING, THEREFORE THE EVENT IS REPORTED IN DOUBT. 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 18579844 ↗
• MalfunctionJan 22, 2024Device Handling Problem; Device Handling Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, REDUCED STAND SPEED WAS REPORTED. THE PATIENT HAD TO BE MOVED AND THE PROCEDURE WAS COMPLETED 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 18551558 ↗
• MalfunctionNov 27, 2023Radiation Output Failure; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION WHILE OPERATING THE ARTIS ZEE FLOOR UNIT. DURING AN EMERGENCY PATIENT PROCEDURE, X-RAY RELEASE BECAME UNAVAILABLE TO THE USER. THE PATIENT HAD TO BE TRANSFERRED, AND THE PROCEDURE WAS COMPLETED 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 18208832 ↗
• MalfunctionNov 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING A PATIENT PROCEDURE, THE PHYSICIAN REPOSITIONED THE RADIATION PROTECTION SCREEN, AND IT WAS HIT BY THE C-ARM. THIS RESULTED IN A PART OF THE LEAD SCREEN BREAKING OFF. ADDITIONALLY PROVIDED INFORMATION STATED THAT THE BROKEN PART OF THE LEAD SCREEN WAS CAUGHT BY THE PLASTIC COVERING OF THE RADIATION PROTECTION SCREEN. 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 18152317 ↗
• MalfunctionNov 10, 2023Poor Quality Image; Poor Quality Image

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR UNIT. DURING DILATATION OF THE CORONARY ARTERY, SOME STRIPES WERE SEEN ON THE LIVE IMAGE. 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 18110296 ↗
• MalfunctionOct 25, 2023Activation Problem; Activation Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR UNIT. DURING A PERCUTANEOUS CORONARY INTERVENTION, THE C-ARM LOST ALL MOVEMENT. THE PATIENT WAS MOVED, AND THE PROCEDURE WAS COMPLETED 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 18005936 ↗
• MalfunctionOct 20, 2023Loss of Power; Loss of Power

  SIEMENS BECAME AWARE OF A MALFUNCTION WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING A PACEMAKER IMPLANTATION PROCEDURE, THE SYSTEM AUTOMATICALLY SHUT DOWN DUE TO A POWER SUPPLY PROBLEM. IT IS UNCLEAR IF THE PACEMAKER WAS SUCCESSFULLY TRANSPLANTED BEFORE THE ISSUE OCCURRED. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ON-GOING; THEREFORE, THE EVENT IS REPORTED IN DOUBT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PERSONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976540 ↗
• MalfunctionSep 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. IT WAS REPORTED THAT THE PATIENT FELL OFF THE TABLE. FOLLOWING THE INCIDENT, SHOULDER X-RAY AND SKULL SCAN WERE PERFORMED, AND NO INJURIES WERE IDENTIFIED. 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 17843490 ↗
• MalfunctionSep 19, 2023Insufficient Device Problem Information; Component Misassembled; Insufficient Device Problem Information; Component Misassembled

  IT WAS REPORTED TO SIEMENS THAT THE SUPPORT ARM (GLASS PANEL) OF THE ARTIS ZEE FLOOR WAS BROKEN AT THE JOINT AND THE SUPPORT ARM WAS JUST HANGING. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING, THEREFORE THE EVENT IS REPORTED IN DOUBT. NO FURTHER INFORMATION IS AVAILABLE AT THIS POINT IN TIME. WE HAVE NO INDICATIONS OF ADVERSE EFFECTS ON THE HEALTH STATUS OF PATIENTS, USERS OR THIRD PARTIES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772587 ↗
• MalfunctionJul 24, 2023Output Problem; Radiation Output Failure; Output Problem; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT NO SYSTEM MOVEMENTS WERE POSSIBLE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386060 ↗
• DeathJul 6, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING A SURGERY TABLE MOVEMENT WAS NO LONGER POSSIBLE. THE PATIENT WITH CARDIAC ISSUES AND SHORTNESS OF BREATH PASSED AWAY IN THE OR. ACCORDING TO THE USER, SIEMENS DEVICE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. THE DEVICE WAS OPERATIONAL FOLLOWING THE INCIDENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THE REPORTED EVENT OCCURRED IN GERMANY.

  Patient problems: Dyspnea; Unspecified Heart Problem

  MAUDE report 14931795 ↗
• MalfunctionApr 25, 2022Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE FLOOR SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE AND THE GENERATOR WAS NOT READY. 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 14191930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122644, K141574, K181407. One submission often covers many models, so check the product and lot details in each record.

• Z-1645-2022 · Aug 10, 2022 · Open, Classified
  Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Ar
• Z-1343-2022 · May 24, 2022 · Terminated
  Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
• Z-0977-2022 · Feb 23, 2022 · Open, Classified
  Artis Q zeego, Model Number 10848283
• Z-0970-2022 · Feb 23, 2022 · Open, Classified
  Artis zee biplane, Model Number 10094141
• Z-0980-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen biplane, Model Number 10848355
• Z-0979-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen ceiling, Model Number 10848354
• Z-0975-2022 · Feb 23, 2022 · Open, Classified
  Artis Q ceiling, Model Number 10848281
• Z-0974-2022 · Feb 23, 2022 · Open, Classified
  Artis Q floor, Model Number 10848280
• Z-0978-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen floor, Model Number 10848353
• Z-0969-2022 · Feb 23, 2022 · Open, Classified
  Artis zee multi-purpose, Model Number 10094139
• Z-0972-2022 · Feb 23, 2022 · Open, Classified
  Artis zee biplane MN, Model Number 10094143
• Z-0976-2022 · Feb 23, 2022 · Open, Classified
  Artis Q biplane, Model Number 10848282
• Z-0971-2022 · Feb 23, 2022 · Open, Classified
  Artis zee floor MN, Model Number 10094142
• Z-0973-2022 · Feb 23, 2022 · Open, Classified
  Artis zeego, Model Number 10280959
• Z-0968-2022 · Feb 23, 2022 · Open, Classified
  Artis zee ceiling, Model Number 10094137

…and 53 more.