Artis zeego 10848283Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04056869010007), received between Jun 15, 2021 and Apr 30, 2026 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

5 FDA recall records name this device's identifier, 4 still open.

85 other recalls cover devices cleared under the same FDA submission (K123529, 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. Aug 10, 2022Class IIOpen, Classified

   Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

   Z-1645-2022 · Root cause: Device Design · Recall details · FDA record ↗

4. May 24, 2022Class IITerminated

   It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.

   Z-1343-2022 · Root cause: Component design/selection · Recall details · FDA record ↗

5. 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-0977-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Use of Device Problem; Device Handling Problem

  SIEMENS WAS INFORMED ABOUT AN ADVERSE EVENT THAT OCCURRED WHILE OPERATING THE ARTIS Q ZEEGO SYSTEM. THE PATIENT, WHO WAS PLACED ON THE TABLE IN THE HYBRID OPERATING THEATRE, FELL FROM THE TABLE. ACCORDING TO THE INFORMATION PROVIDED, THE INCIDENT WAS DESCRIBED AS AN ASSISTED FALL OR A SLIDE. THE PATIENT LATER PASSED AWAY; HOWEVER, IT WAS CONFIRMED THAT THE FALL DID NOT CONTRIBUTE TO THE DEATH. NO CAUSAL RELATIONSHIP BETWEEN DEVICE PERFORMANCE AND THE PATIENT¿S DEATH WAS IDENTIFIED.

  Patient problems: Fall

  MAUDE report 25043552 ↗
• MalfunctionSep 23, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, A SYSTEM MALFUNCTION AND SYNCHRONIZATION FAILURE TO THE DATABASE OCCURRED. ADDITIONAL INFORMATION WAS PROVIDED THAT A PATIENT MAY HAVE SUFFERED AN INJURY TO THE KIDNEY. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Insufficient Information; Renal Impairment

  MAUDE report 20278185 ↗
• InjuryFeb 19, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTS Q ZEEGO SYSTEM DURING AN EMERGENCY PROCEDURE. IT WAS STATED BY THE USER THAT DURING THE SYSTEM START-UP, ALL SYSTEM MOVEMENTS WERE BLOCKED AND AN ERROR MESSAGE ¿COLLISION CONTROL DEACTIVATED¿ WAS DISPLAYED TO THE USER. DUE TO THIS ISSUE THE EMERGENCY PATIENT PROCEDURE THAT WAS PLANNED ON THE CONCERNED UNIT HAD TO BE PERFORMED WITH AN ALTERNATE MOBILE C-ARM SYSTEM. ADDITIONAL INFORMATION STATING THAT THE PATIENT PASSED AWAY WAS PROVIDED TO SIEMENS. THE RELATIONSHIP BETWEEN THE SYSTEM BEHAVIOR AND THE PATIENT'S DEATH IS UNKNOWN AS OF THE DATE OF THIS REPORT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18731301 ↗
• MalfunctionNov 17, 2023Unintended Collision; Unintended Collision

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS Q ZEEGO SYSTEM. IT WAS REPORTED THAT THE C-ARM CRASHED INTO THE STAND. 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 18160761 ↗
• DeathApr 27, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS Q ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, SYSTEM MOVEMENT WAS BLOCKED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT PASSED AWAY AND THE USER DID NOT USE PATIENT RESCUE ON THE ARTIS Q ZEEGO. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 14217070 ↗
• MalfunctionAug 27, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT C-ARM MOVEMENT WAS NOT POSSIBLE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. DURING TRANSFER TO AN ALTERNATE TABLE, THE SHEATH IN THE PATIENT WAS PULLED OUT. PRESSURE WAS APPLIED TO STOP BLEEDING. 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 12377035 ↗
• MalfunctionJun 15, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q ZEEGO SYSTEM. THE USER REPORTED THAT THE CARRIER ARM OF THE MONITOR PARTIALLY FELL OUT OF THE SUPPORT RAILS BECAUSE THE END STOPS WERE NOT PRESENT. 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 11998697 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123529, K181407. One submission often covers many models, so check the product and lot details in each record.

• Z-0974-2022 · Feb 23, 2022 · Open, Classified
  Artis Q floor, Model Number 10848280
• Z-0973-2022 · Feb 23, 2022 · Open, Classified
  Artis zeego, Model Number 10280959
• Z-0978-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen floor, Model Number 10848353
• Z-0980-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen biplane, Model Number 10848355
• Z-0970-2022 · Feb 23, 2022 · Open, Classified
  Artis zee biplane, Model Number 10094141
• Z-0972-2022 · Feb 23, 2022 · Open, Classified
  Artis zee biplane MN, Model Number 10094143
• Z-0979-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen ceiling, Model Number 10848354
• Z-0976-2022 · Feb 23, 2022 · Open, Classified
  Artis Q biplane, Model Number 10848282
• Z-0968-2022 · Feb 23, 2022 · Open, Classified
  Artis zee ceiling, Model Number 10094137
• Z-0969-2022 · Feb 23, 2022 · Open, Classified
  Artis zee multi-purpose, Model Number 10094139
• Z-0967-2022 · Feb 23, 2022 · Open, Classified
  Artis zee floor, Model Number 10094135
• Z-0975-2022 · Feb 23, 2022 · Open, Classified
  Artis Q ceiling, Model Number 10848281
• Z-0971-2022 · Feb 23, 2022 · Open, Classified
  Artis zee floor MN, Model Number 10094142
• Z-0305-2022 · Oct 20, 2021 · Terminated
  Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10848355
• Z-0301-2022 · Oct 20, 2021 · Terminated
  Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281

…and 70 more.