Artis Q floor 10848280Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04056869009971), received between Aug 18, 2020 and Apr 13, 2026 — classified as 3 injuries, 15 malfunctions.

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

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

86 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. 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-0974-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  SIEMENS WAS INFORMED ABOUT AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. DURING A PROCEDURE, THE CARDIOLOGIST REQUESTED ACTIVATION OF THE CODE BLUE TEAM AFTER THE PATIENT EXPERIENCED A SUDDEN DETERIORATION FOLLOWING PLACEMENT IN THE SUPINE POSITION. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED; HOWEVER, THE PATIENT SUBSEQUENTLY PASSED AWAY. SIEMENS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT. AT THIS TIME, A RELATIONSHIP BETWEEN THE PATIENT¿S DEATH AND USE OF THE DEVICE HAS NOT YET BEEN ESTABLISHED.

  Patient problems: Insufficient Information

  MAUDE report 24858294 ↗
• MalfunctionFeb 6, 2026Failure to Transmit Record

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q FLOOR DEVICE. THE USER REPORTED THAT THE SYSTEM NEITHER GENERATED A DOSE REPORT NOR DISPLAYED IT ON THE MONITOR. ADDITIONAL INFORMATION WAS PROVIDED THAT THE ISSUE OCCURRED DURING A PATIENT PROCEDURE, WHICH WAS CONTINUED ON THE SAME 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 24282724 ↗
• MalfunctionNov 27, 2023Radiation Output Failure; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q FLOOR UNIT. DURING AN EMERGENCY CARDIOVASCULAR PROCEDURE, X-RAY RELEASE ON THE SYSTEM WAS UNAVAILABLE. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 15 MINUTES AND THEN CONTINUED FOLLOWING COMPLETE SYSTEM REBOOT. 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 18208925 ↗
• MalfunctionNov 8, 2023No Display/Image; No Display/Image

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. AN UNSTABLE STEMI (ST-ELEVATION MYOCARDIAL INFARCTION) PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS TAKEN TO THE ANGIO EXAM ROOM, HOWEVER, PRIOR TO STARTING THE EXAMINATION IT WAS DISCOVERED THAT NO IMAGES WERE VISIBLE, AND THE PATIENT TABLE COULD NOT BE MOVED. AFTER THE REBOOT THE SYSTEM WOULD NOT START. THE PATIENT WAS MOVED, AND THE PROCEDURE WAS SUCCESSFULLY 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 18092855 ↗
• MalfunctionSep 8, 2023Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM, DURING AN EMERGENCY PROCEDURE, THE SYSTEM FROZE AND WAS NOT OPERABLE. THE PROCEDURE HAD TO BE CANCELLED BY THE USER. 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 17710365 ↗
• InjuryAug 7, 2023Use of Device Problem; Use of Device Problem

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WITH THE ARTIS Q FLOOR SYSTEM. THE CUSTOMER USES THE NARROW TABLETOP CONFIGURATION WITH THE ARTIS Q FLOOR SYSTEM. TO INCREASE THE WIDTH OF THE TABLE FOR LARGER PATIENTS, PLEXIGLASS PANELS ARE USED UNDER THE SYSTEM MATTRESS. THESE PLEXIGLASS PANELS WERE SOURCED BY THE CUSTOMER INTERNALLY AND ARE NOT APPROVED/PROVIDED BY SIEMENS. DURING PATIENT TRANSFER TO THE TABLE WITH NO SYSTEM MOVEMENT, A STAFF MEMBER CAUGHT HER HAND AGAINST THIS PLEXIGLASS, FRACTURING A FINGER.

  Patient problems: Bone Fracture(s)

  MAUDE report 17469400 ↗
• MalfunctionJul 22, 2022Output Problem; Radiation Output Failure; Output Problem; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE FOLLOWING ERROR WAS DISPLAYED "NO XRAY TUBE TOO HOT". 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 AUSTRALIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15083696 ↗
• MalfunctionApr 15, 2022Data Problem

  SIEMENS SYSTEM WILL NOT TRANSFER XRAY IMAGES TO PACS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117758 ↗
• MalfunctionFeb 23, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE UNIT UNEXPECTEDLY SHUT DOWN. 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 13583471 ↗
• MalfunctionDec 20, 2021Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT 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 13042746 ↗
• MalfunctionJun 9, 2021Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT X-RAY 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 11966507 ↗
• InjuryMay 10, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. THE USER REPORTED THAT A NURSE SUFFERED AN INJURY DURING C-ARM MOVEMENT WHICH REQUIRED STITCHES. THERE IS NO REPORT OF FURTHER 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: Unspecified Musculoskeletal problem

  MAUDE report 11797984 ↗
• MalfunctionMay 5, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. DURING AN INTERVENTINAL PROCEDURE, THE USER REPORTED THAT THE SYSTEM WENT DOWN. 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 11776692 ↗
• MalfunctionMar 22, 2021Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT FLUORO WAS ABORTED AND THE X-RAY TUBE WAS DEFECTIVE. 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 11542363 ↗
• MalfunctionMar 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS 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 11398036 ↗
• MalfunctionFeb 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. THE USER REPORTED THAT THE IMAGE QUALITY WAS IN A RANGE THAT MULTIPLE INJECTIONS OF THE CONTRAST MEDIUM WITH DIFFERENT EXAM SETS WAS REQUIRED IN ORDER TO SEE THE VESSEL. AT THIS TIME, 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 11331638 ↗
• MalfunctionOct 15, 2020Contamination; Contamination /Decontamination Problem; Unexpected/Unintended Radiation Output; Contamination; Contamination /Decontamination Problem; Unexpected/Unintended Radiation Output

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. THE USER REPORTED THAT THE FOOT SWITCH PEDAL BECAME STUCK, AND RELEASED X-RAYS. 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 10683253 ↗
• InjuryAug 18, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS Q FLOOR SYSTEM. THE USER REPORTED BAD IMAGE QUALITY DURING AN EXAMINATION IN WHICH A PATIENT SUFFERED AN ARTERIAL DISSECTION. THE DISSECTION WAS REPAIRED WITH A STENT AND THERE ARE NO REPERCUSSIONS TO THE PATIENTS HEALTH. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Injury; Perforation

  MAUDE report 10419310 ↗

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-1343-2022 · May 24, 2022 · Terminated
  Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
• Z-0972-2022 · Feb 23, 2022 · Open, Classified
  Artis zee biplane MN, Model Number 10094143
• 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-0976-2022 · Feb 23, 2022 · Open, Classified
  Artis Q biplane, Model Number 10848282
• 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
• Z-0970-2022 · Feb 23, 2022 · Open, Classified
  Artis zee biplane, Model Number 10094141
• Z-0978-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen floor, Model Number 10848353
• Z-0975-2022 · Feb 23, 2022 · Open, Classified
  Artis Q ceiling, Model Number 10848281
• Z-0977-2022 · Feb 23, 2022 · Open, Classified
  Artis Q zeego, Model Number 10848283
• Z-0971-2022 · Feb 23, 2022 · Open, Classified
  Artis zee floor MN, Model Number 10094142
• Z-0979-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen ceiling, Model Number 10848354
• Z-0980-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen biplane, Model Number 10848355
• Z-0304-2022 · Oct 20, 2021 · Terminated
  Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354

…and 71 more.