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Artis Q ceiling 10848281Recalls & reported problems

Siemens Healthcare GmbH · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Siemens Artis Q ceiling is a ceiling-mounted X-ray imaging system used for procedures like heart catheterization. The 49 reports mostly describe the system losing X-ray output or blank screens mid-procedure, and a stand that would not move, so patients had to be moved to another machine. There is 1 death and 2 injuries. Four open recalls cover low coolant that undercools the X-ray tube, failure to fully start after an abrupt shutdown, and a tube hardware issue that can block X-ray.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
49
Deaths reported
1
Injuries reported
2
Recalls naming it
4

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 04056869009988), received between Aug 19, 2020 and Mar 11, 2026 — classified as 1 death, 2 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Radiation Output Failure” (8 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 2 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 2 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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-0975-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Radiation Output Failure8
  • Electrical /Electronic Property Problem6
  • Mechanical Problem5
  • Detachment of Device or Device Component4
  • No Apparent Adverse Event4
  • Output Problem4
  • Overheating of Device3
  • Radiation Output Problem3

Patient problems

  • No Clinical Signs, Symptoms or Conditions42
  • Cardiac Arrest2
  • Bruise/Contusion1
  • Coma1
  • Failure of Implant1
  • Head Injury1
  • Hemorrhage/Blood Loss/Bleeding1
  • Insufficient Information1

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 11, 2026Mechanical Problem

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. DURING AN EMERGENCY PROCEDURE ON THE PATIENT WITH ACUTE MYOCARDIAL INFARCTION, THE SYSTEM MOVEMENTS WERE NOT POSSIBLE. THE USER TRIED RESTARTING THE MACHINE, BUT THE SYSTEM STILL COULD NOT BE MOVED. 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 24569062 ↗
  • MalfunctionFeb 4, 2026Radiation Output Failure

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q CEILING UNIT. DURING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY WAS AVAILABLE AND THE USER WAS UNABLE TO GET ANY IMAGES. 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 24257681 ↗
  • MalfunctionJan 30, 2026Defective Component; Radiation Output Failure

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q CEILING UNIT. DURING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY WAS AVAILABLE. THE PATIENT HAD TO BE MOVED TO COMPLETE THE PROCEDURE ON AN ALTERNATE UNIT. IT IS ASSUMED THAT AN X-RAY TUBE WAS DEFECTIVE. 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 24220439 ↗
  • MalfunctionJan 2, 2026No Display/Image

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. DURING AN EMERGENCY CARDIAC INTERVENTIONAL SURGERY, THE CARDIOLOGIST WAS UNABLE TO OBTAIN IMAGING DUE TO THE GANTRY SCREEN BEING BLACK AND UNABLE TO DISPLAY IMAGES. THE PATIENT WAS RELOCATED TO A DIFFERENT MEDICAL FACILITY, 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 23943169 ↗
  • MalfunctionDec 15, 2025Intermittent Continuity; Intermittent Continuity

    IT WAS REPORTED TO SIEMENS HEALTHINEERS ON (B)(6) 2025 THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING. A PATIENT WITH A MYOCARDIAL INFARCTION WAS ADMITTED TO THE CATHETERIZATION LAB FOR SURGERY. AFTER THE EQUIPMENT WAS TURNED ON, THE LARGE SCREEN IN THE CATHETERIZATION LAB SHOWED NO SIGNAL, PREVENTING THE DOCTOR FROM PERFORMING THE CATHETER PLACEMENT PROCEDURE. THE OPERATOR IMMEDIATELY CALLED SIEMENS HEALTHINEERS CUSTOMER SERVICE HOTLINE WHO DIRECTED THE CUSTOMER TO UNPLUG AND PLUG THE SIGNAL CABLE AT THE BACK OF THE MAIN UNIT. AFTER RESTARTING, THE DEVICE RETURNED TO NORMAL. THE ENTIRE PROCESS TOOK APPROXIMATELY 20 MINUTES, WHICH DELAYED THE PATIENT'S SURGERY TO SOME EXTENT. AFTER THE DEVICE WAS RESTORED, THE SURGERY PROCEEDED SMOOTHLY, AND THE PATIENT RECOVERED WELL POST-SURGERY. 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 23802018 ↗
  • MalfunctionJul 11, 2025No Display/Image; No Display/Image

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE MONITOR STOPPED WORKING. THE PATIENT WAS MOVED FOR THE PROCEDURE TO BE CONTINUED ON 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 22479455 ↗
  • InjuryFeb 7, 2025Mechanics Altered; Mechanics Altered

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. IT WAS REPORTED THAT THE OVERLAY OF THE ANGIO AND CT SYSTEMS SHOWED AN OFFSET OF 6 CM. ADDITIONAL INFORMATION WAS PROVIDED THAT DURING A PATIENT PROCEDURE A MARKING FOR NEEDLE GUIDANCE SHOWED A DIFFERENCE OF 6 CM, RESULTING IN MISTAKENLY STABBING THE PATIENT'S STOMACH WALL, CAUSING BLEEDING. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 21334951 ↗
  • MalfunctionOct 21, 2024Positioning Failure; Positioning Failure

    SIEMENS HEALTHINEERS WAS INFORMED BY ITS SERVICE ORGANIZATION ABOUT AN ISSUE WITH THE ARTIS Q CEILING SYSTEM. THE STAND COULD NOT MOVE. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE MALFUNCTION OCCURRED DURING AN EMERGENCY PROCEDURE, WHICH WAS CONTINUED AND FINISHED USING AN ALTERNATIVE SYSTEM. SIEMENS HEALTHINEERS HAS NO INDICATION OF ANY ADVERSE EFFECTS TO THE HEALTH STATUS OF THE INVOLVED PATIENT DUE TO THE REPORTED ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20500327 ↗
  • MalfunctionAug 7, 2024Unintended Collision; Use of Device Problem; Insufficient Device Problem Information; Unintended Collision; Use of Device Problem; Insufficient Device Problem Information

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. DURING A CEREBRAL ANEURYSM EMBOLIZATION PROCEDURE, SYSTEM MOVEMENT WAS BLOCKED. THIS FAILURE LED TO A 30-MINUTE TREATMENT DELAY. 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 19929436 ↗
  • MalfunctionJul 23, 2024Electrical /Electronic Property Problem; Failure to Power Up; Radiation Output Problem; Electrical /Electronic Property Problem; Failure to Power Up; Radiation Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. AT THE START UP OF AN EMERGENCY PROCEDURE, MESSAGES REGARDING MEMORY ISSUES WERE DISPLAYED, RESULTING IN A DELAY. 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 19804893 ↗
  • MalfunctionJul 23, 2024Electrical /Electronic Property Problem; Failure to Power Up; Radiation Output Problem; Electrical /Electronic Property Problem; Failure to Power Up; Radiation Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. AT THE START UP OF AN EMERGENCY PROCEDURE, MESSAGES REGARDING MEMORY ISSUES WERE DISPLAYED, RESULTING IN A DELAY. 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: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

    MAUDE report 19804887 ↗
  • MalfunctionMar 12, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS Q CEILING UNIT. INFORMATION WAS PROVIDED THAT A PATIENT FELL OFF THE TABLE AND SUFFERED A MINOR INJURY TO THE HEAD. THE PATIENT WAS KEPT AT THE FACILITY FOR OBSERVATION AND WAS REPORTED TO BE DOING WELL. NO OTHER ISSUES HAVE BEEN REPORTED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION ABOUT THIS EVENT.

    Patient problems: Head Injury

    MAUDE report 18885964 ↗
  • MalfunctionDec 12, 2023Unintended Movement; Unintended Movement

    SIEMENS BECAME AWARE ON AN UNINTENDED SYSTEM MOVEMENT WHILE OPERATING THE ARTIS Q CEILING SYSTEM. THE OPERATOR REPORTED THE TABLE CRADLE MOVE FROM HORIZONTAL POSITION TO PATIENT LEFT END STOP AND THEN BACK TO PATIENT RIGHT END STOP WITHOUT GIVEN COMMANDS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE FAILURE OCCURRED DURING A PATIENT PROCEDURE WHICH CAUSED A DELAY. 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 18313052 ↗
  • MalfunctionDec 5, 2023Radiation Output Failure; Radiation Output Failure

    SIEMENS BECAME AWARE OF A MALFUNCTION WHILE OPERATING THE ARTIS Q CEILING SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE USER WAS UNABLE TO RELEASE RADIATION. THIS SYSTEM FAILURE RESULTED IN A LONG-TERM EXAMINATION DELAY OF A PATIENT WITH A STROKE. 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 18266462 ↗
  • MalfunctionSep 5, 2023Detachment of Device or Device Component; Component Misassembled; Detachment of Device or Device Component; Component Misassembled

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. WHILE MOVING THE CEILING STAND FROM THE PATIENT TRANSFER POSITION TO THE TABLE, THE CLAMP THAT HOLDS THE HOSE FOR THE CEILING STAND CAME OFF AND ALMOST HIT A PHYSICIAN IN THE HEAD. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE PERSONS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17682051 ↗
  • MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    SIEMENS BECAME AWARE OF AN ISSUE WITH THE ARTIS Q CEILING SYSTEM. THE VELCRO STRAP THAT SECURES MATTRESS TO THE PATIENT TABLE CAME OFF. THE MATTRESS IS NOW INSECURE AND CAN SLIDE SIDEWAYS DURING PATIENT POSITIONING. THIS INCREASES RISK OF PATIENTS POTENTIALLY FALLING OFF THE TABLE, THOUGH, WE ARE UNAWARE OF ANY ADVERSE IMPACT TO THE STATE OF HEALTH OF THE PATIENTS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17595456 ↗
  • MalfunctionJul 25, 2023Output Problem; Radiation Output Failure; Output Problem; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT X-RAY COULD NOT BE RELEASED. 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 17392684 ↗
  • MalfunctionJul 24, 2023No Device Output; No Device Output

    ON 2023-07-03, THE MANUFACTURER WAS INFORMED BY ITS SERVICE ORGANIZATION THAT X-RAY RELEASE WAS NOT POSSIBLE USING THE ARTIS Q CEILING SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED ON 2023-07-20 (NEW AWARENESS DATE) THAT THE FAILURE OCCURRED DURING AN EMERGENCY PROCEDURE AND THE PATIENT HAD TO BE RELOCATED TO AN ALTERNATIVE SYSTEM TO FINISH THE MEDICAL PROCEDURE. THE PATIENT FELL INTO A SHALLOW COMA. AFTER THE OPERATION, THE PATIENT'S VITAL SIGNS WERE STABLE. AFTER AN INQUIRY TO THE CUSTOMER, IT WAS CONFIRMED THAT THE OPERATION WAS SUCCESSFUL, AND THE PATIENT IS NO LONGER IN A COMA.

    Patient problems: Coma

    MAUDE report 17386158 ↗
  • 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 Q CEILING SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED AN ERROR MESSAGE THAT THE TUBE WAS TOO HOT AND THE SYSTEM SWITCHED TO 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17385975 ↗
  • MalfunctionSep 8, 2022Output Problem; Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. THE TRANSMISSION OF 3D IMAGE OF CONE-BEAM COMPUTED TOMOGRAPHY (CBCT) FAILED DURING AN INTERVENTIONAL PROCEDURE, ACCORDING TO THE USER. THE PROCEDURE WAS CONTINUED AND COMPLETED ON THE CONCERNED UNIT. SIEMENS IS NOT AWARE OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THE REPORTED EVENT OCCURRED IN CHINA.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15379424 ↗
  • MalfunctionAug 24, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. A DISPLAY CEILING SUSPENSION FELL OUT OF THE TRACKS AND WAS FOUND ON THE FLOOR. NO PERSONS WERE INVOLVED IN THE REPORTED INCIDENT. 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 15282639 ↗
  • MalfunctionAug 8, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property 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 X-RAY WAS POSSIBLE AND A BURNING ODOR WAS OBSERVED IN THE ENGINE ROOM. 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 15182191 ↗
  • MalfunctionMay 5, 2022Radiation Output Failure; Radiation Output Failure

    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 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 14285924 ↗
  • MalfunctionApr 13, 2022Overheating of Device; Overheating of Device

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED A PROBLEM WITH 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 14101108 ↗
  • MalfunctionApr 7, 2022Radiation Output Failure; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED AN ERROR. 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 14040009 ↗

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-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-0978-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen floor, Model Number 10848353
  • Z-0970-2022 · Feb 23, 2022 · Open, Classified
    Artis zee biplane, Model Number 10094141
  • Z-0967-2022 · Feb 23, 2022 · Open, Classified
    Artis zee floor, Model Number 10094135
  • Z-0979-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen ceiling, Model Number 10848354
  • Z-0968-2022 · Feb 23, 2022 · Open, Classified
    Artis zee ceiling, Model Number 10094137
  • 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-0980-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen biplane, Model Number 10848355
  • Z-0973-2022 · Feb 23, 2022 · Open, Classified
    Artis zeego, Model Number 10280959
  • 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-0302-2022 · Oct 20, 2021 · Terminated
    Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282

…and 71 more.

Other System, x-ray, angiographic devices

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Sources and updates

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