Artis Q.zen ceiling 10848354Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04056869010021), received between Sep 10, 2020 and Feb 24, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 16, 2026.

Recalls naming this device

1. Mar 21, 2024Open, 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, 2022Open, 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, 2022Open, 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, 2022Open, 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-0979-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Radiation Output Problem; Radiation Output Failure; Radiation Output Problem; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q.ZEN CEILING SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE X-RAY FUNCTIONALITY WAS BLOCKED. 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 21448623 ↗
• MalfunctionJul 20, 2022Radiation Overexposure; Radiation Overexposure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN CEILING SYSTEM. THE USER REPORTED THAT THE INTERVENTIONAL PROCEDURE LASTED FOR AN EXTENDED PERIOD OF TIME, RESULTING IN A HIGH ACCUMULATED RADIATION DOSAGE TO THE PATIENT. AT THIS TIME, THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF THE PATIENT. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED ON THE CONCERNED UNIT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THE REPORTED EVENT OCCURRED IN SWITZERLAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067336 ↗
• MalfunctionMay 19, 2022Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED TUBE FILAMENT ERRORS AND LOST X-RAY. 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 14433362 ↗
• MalfunctionFeb 1, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN CEILING SYSTEM. THE USER REPORTED THAT THE ACCESSORY RAIL; COMPLETE WITH THE MOUNTED LEAD SHIELD AND CONTROL MODULES, CAME OUT AND FELL ON THE NURSE'S FEET. AT THIS TIME, 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 13412401 ↗
• MalfunctionJan 17, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN CEILING 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 13266013 ↗
• MalfunctionFeb 26, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN CEILING 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 11385077 ↗
• MalfunctionFeb 1, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO MOVEMENT 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 11257812 ↗
• MalfunctionNov 10, 2020Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q.ZEN CEILING 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 10815668 ↗
• InjuryOct 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS Q.ZEN CEILING SYSTEM. THE USER REPORTED THAT THE TABLE HEAD END HOLDER SLID FROM THE TABLE AND LANDED ON THE OPERATORS TOES. INFORMATION WAS PROVIDED THAT THE OPERATORS FOOT IS SORE, HOWEVER, IT IS NOT CLEAR IF ANY MEDICAL TREATMENT WAS NEEDED. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10683130 ↗
• MalfunctionSep 10, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO SYSTEM MOVEMENT 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 10514078 ↗

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-0969-2022 · Feb 23, 2022 · Open, Classified
  Artis zee multi-purpose, Model Number 10094139
• 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-0977-2022 · Feb 23, 2022 · Open, Classified
  Artis Q zeego, Model Number 10848283
• Z-0974-2022 · Feb 23, 2022 · Open, Classified
  Artis Q floor, Model Number 10848280
• Z-0980-2022 · Feb 23, 2022 · Open, Classified
  Artis Q.zen biplane, Model Number 10848355
• Z-0967-2022 · Feb 23, 2022 · Open, Classified
  Artis zee floor, Model Number 10094135
• Z-0971-2022 · Feb 23, 2022 · Open, Classified
  Artis zee floor MN, Model Number 10094142
• Z-0975-2022 · Feb 23, 2022 · Open, Classified
  Artis Q ceiling, Model Number 10848281
• 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-0976-2022 · Feb 23, 2022 · Open, Classified
  Artis Q biplane, Model Number 10848282
• Z-0972-2022 · Feb 23, 2022 · Open, Classified
  Artis zee biplane MN, Model Number 10094143
• Z-0300-2022 · Oct 20, 2021 · Terminated
  Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280

…and 71 more.