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Artis Q biplane 10848282Recalls & reported problems

Siemens Healthcare GmbH · Class 2

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

Quick summary

The Siemens Artis Q biplane is a fluoroscopy X-ray system used for imaging during interventional procedures. Most of the 46 reports describe the system failing to produce X-ray or losing image processing mid-procedure, sometimes forcing clinicians to move the patient to another machine. Reports include 1 death and 2 injuries. Four recalls are open, the most recent from March 2024, over low coolant levels that leave the X-ray tube insufficiently cooled and the system unable to run normally.

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
46
Deaths reported
1
Injuries reported
2
Recalls naming it
4

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04056869009995), received between Jun 15, 2020 and Feb 18, 2026 — classified as 1 death, 2 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Output Problem” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
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 · 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 · 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 · 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-0976-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

  • Output Problem8
  • Radiation Output Failure8
  • Radiation Output Problem5
  • Insufficient Device Problem Information4
  • Mechanical Problem4
  • No Apparent Adverse Event4
  • Display or Visual Feedback Problem3
  • No Device Output3

Patient problems

  • No Clinical Signs, Symptoms or Conditions40
  • Cardiac Arrest1
  • Injury1
  • Insufficient Information1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1
  • Perforation1

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 18, 2026Failure to Power Up; Power Problem; Activation Failure

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE SYSTEM WOULD NOT POWER UP. THE PATIENT HAD TO BE MOVED TO COMPLETE THE PROCEDURE ON AN ALTERNATE UNIT. NO INJURIES OR ADVERSE HEALTH EFFECTS HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24376679 ↗
  • MalfunctionDec 3, 2025Unexpected Shutdown; Unexpected Shutdown

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE. NO 3D RUN WAS POSSIBLE ON THE SYSTEM DURING A NEUROLOGY INTERVENTIONAL PROCEDURE. ADDITIONAL INFORMATION CONFIRMS THAT THE PROCEDURE WAS STOPPED AND POSTPONED WITHOUT ANY COMPLICATION TO THE PATIENT. 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 23705224 ↗
  • MalfunctionNov 17, 2025No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

    IMAGE PROCESS PROBLEM DURING OPERATION. HOSPITAL¿S AE REPORT DESCRIBED INCIDENT AS ¿ON (B)(6) 2025, A PATIENT UNDERWENT SEMI-PERMANENT VENOUS CATHETER PLACEMENT AND REMOVAL SURGERY USING A SIEMENS ARTIS BIPLANE X-RAY ANGIOGRAPHY SYSTEM IN THE INTERVENTIONAL OPERATING ROOM OF (B)(6). DURING THE PROCEDURE, THE IMAGE PROCESSING SYSTEM WENT BLACK, BUT RECOVERED AFTER MULTIPLE RESTARTS. FURTHER EXAMINATION DETERMINED A FAULTY IMAGE PROCESSING BOARD, AND THE MANUFACTURER WAS CONTACTED FOR IMMEDIATE REPLACEMENT." NOTIFICATION NO. IS (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23568962 ↗
  • MalfunctionAug 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE UNIT. AN ERROR WITH THE COLLIMATOR COPPER FILTER WAS REPORTED. 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 PATIENT INVOLVED.

    Patient problems: Insufficient Information

    MAUDE report 22903990 ↗
  • MalfunctionApr 23, 2025Radiation Output Failure; Radiation Output Failure

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATE SYSTEM. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21891437 ↗
  • MalfunctionMar 25, 2025Radiation Output Failure; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE USING THE ARTIS Q BIPLANE. DURING AN EMERGENCY PROCEDURE, THE USER STATED THAT NO X-RAY WAS POSSIBLE ON PLANE A. THE PROCEDURE WAS CONTINUED AND FINISHED AT AN ALTERNATIVE HOSPITAL. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21687014 ↗
  • MalfunctionOct 8, 2024Radiation Output Problem; Radiation Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. THE USER REPORTED THAT DURING AN EMERGENCY PROCEDURE, 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. 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 20394993 ↗
  • MalfunctionAug 22, 2024Radiation Output Problem; Radiation Output Problem

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY WAS POSSIBLE. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED USING 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 20038573 ↗
  • DeathNov 10, 2023Poor Quality Image; Poor Quality Image

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE FOR DEVICE IMPLANTATION, THE DISPLAYED DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) ROADMAP WAS VERY HAZY WITH NO VESSEL BORDERS VISIBLE TO THE USER. THE ISSUE OCCURRED DURING DILATION OF THE CORONARY ARTERY. ACCORDING TO THE ADDITIONALLY PROVIDED INFORMATION, THE IMAGES LOOKED AS THERE WAS A LOT OF MOVEMENT, THOUGH THE PATIENT WAS UNDER GENERAL ANESTHESIA UNABLE TO MOVE. MULTIPLE CINES WERE REPEATED WITH CONTRAST; HOWEVER, THIS DID NOT IMPROVE IMAGE QUALITY. THE USER CONTINUED THE PROCEDURE DESPITE THE POOR IMAGE QUALITY. SIEMENS WAS INFORMED THAT A CEREBRAL ANEURYSM PERFORATION BY WIRE HAD OCCURRED DURING THIS PROCEDURE. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS PROVIDED TO SIEMENS STATING THAT THE PATIENT PASSED AWAY.

    Patient problems: Perforation

    MAUDE report 18112241 ↗
  • MalfunctionOct 25, 2023Radiation Output Failure; Radiation Output Failure

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE UNIT. DURING AN EMERGENCY PROCEDURE, NO X-RAY EXPOSURE WAS POSSIBLE. 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 18006530 ↗
  • MalfunctionOct 23, 2023No Device Output; Application Program Freezes or Fails to Launch; No Device Output; Application Program Freezes or Fails to Launch

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE MACHINE WENT INTO THE BYPASS MODE. THE USER TRIED TO REBOOT THE UNIT BUT WAS UNABLE TO BRING THE SYSTEM BACK UP. THE PATIENT HAD TO BE MOVED TO AN ALTERNATE UNIT. WE ARE UNAWARE OF ANY ADVERSE IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17985649 ↗
  • MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    SIEMENS BECAME AWARE OF AN ISSUE WITH THE ARTIS Q BIPLANE 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 17595307 ↗
  • 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 BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, IT WAS 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 17386116 ↗
  • MalfunctionOct 11, 2022Output Problem; Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN ON-GOING NEURO EXAMINATION, THE CONCERNED UNITS CAN ONLY BE MOVED IN SLOW MOTION AND NO AUTOMATIC OR 3D RUNS WERE POSSIBLE. THE PATIENT HAD TO BE MOVED; 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. THE REPORTED EVENT OCCURRED IN GERMANY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15577224 ↗
  • MalfunctionSep 29, 2022Mechanical Problem; No Device Output; Mechanical Problem; No Device Output

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. THE USER REPORTED THAT NO SYSTEM MOVEMENTS WERE AVAILABLE DURING AN INTERVENTIONAL PROCEDURE. THE MALFUNCTION OCCURRED IN THE BEGINNING STATES OF THE PROCEDURE. THE MEDICAL PROCEDURE WAS TERMINATED. 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 NORWAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15502782 ↗
  • MalfunctionJun 15, 2022Radiation Output Failure; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED RECEIVING AN A-PLANE TOO HOT ERROR MESSAGE. 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 14693392 ↗
  • MalfunctionJun 6, 2022Output Problem; Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. THE USER REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE ALL MOTOR MOVEMENTS WERE BLOCKED. THE PROCEDURE WAS COMPLETED ON AN ALTERNATE UNIT. AT THIS TIME, WE HAVE NO INDICATION 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. THE REPORTED EVENT OCCURRED IN (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14601588 ↗
  • MalfunctionMay 31, 2022No Device Output; No Device Output

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN INTERVENTAIONAL PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE AND MOVEMENTS WERE BLOCKED. 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 14546230 ↗
  • MalfunctionMay 16, 2022Output Problem; Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, A STENT WAS INSERTED, HOWEVER, THE USER WAS UNABLE TO SEE THE LOCATION OF THE STENT. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED ON THE SAME UNIT. 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 (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14407626 ↗
  • MalfunctionMay 11, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED AN ERROR WITH THE BYPASS MODULE. 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 14351074 ↗
  • MalfunctionApr 4, 2022Excessive Heating; Excessive Heating

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. THE USER REPORTED THAT NO EMERGENCY X-RAY AND BYPASS WERE POSSIBLE. AT THIS TIME, WE HAVE NO INDICATION 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 13993612 ↗
  • MalfunctionDec 20, 2021No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THEY COULD NOT RAISE OR LOWER THE TABLE. 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 13042743 ↗
  • MalfunctionDec 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. THE CUSTOMER REPORTED HAVING PROBLEMS MOVING THE TABLE AND GANTRY DURING CPR. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT RESUSCITATION FAILED AND THE PATIENT PASSED AWAY. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Patient problems: Cardiac Arrest

    MAUDE report 13017823 ↗
  • MalfunctionDec 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED NO 3D OR COMMUNICATION WITH THE WIDESCREEN CONTROL UNIT. THE PROCEDURE WAS STOPPED DUE TO THE FAILURE. 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 12982567 ↗
  • MalfunctionNov 10, 2021Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE LIVE X-RAY IMAGE WAS NOT DISPLAYED. 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 12786161 ↗

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-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-0970-2022 · Feb 23, 2022 · Open, Classified
    Artis zee biplane, Model Number 10094141
  • Z-0979-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen ceiling, Model Number 10848354
  • Z-0967-2022 · Feb 23, 2022 · Open, Classified
    Artis zee floor, Model Number 10094135
  • Z-0968-2022 · Feb 23, 2022 · Open, Classified
    Artis zee ceiling, Model Number 10094137
  • Z-0974-2022 · Feb 23, 2022 · Open, Classified
    Artis Q floor, Model Number 10848280
  • Z-0969-2022 · Feb 23, 2022 · Open, Classified
    Artis zee multi-purpose, Model Number 10094139
  • Z-0978-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen floor, Model Number 10848353
  • Z-0973-2022 · Feb 23, 2022 · Open, Classified
    Artis zeego, Model Number 10280959
  • Z-0980-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen biplane, Model Number 10848355
  • Z-0972-2022 · Feb 23, 2022 · Open, Classified
    Artis zee biplane MN, Model Number 10094143
  • Z-0971-2022 · Feb 23, 2022 · Open, Classified
    Artis zee floor MN, Model Number 10094142
  • Z-0296-2022 · Oct 20, 2021 · Terminated
    Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135

…and 71 more.

Other System, x-ray, fluoroscopic, image-intensified devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.