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Artis zee ceiling 10094137Recalls & reported problems

Siemens Healthcare GmbH · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Quick summary

This Siemens Artis zee ceiling CT X-ray system has 91 adverse event reports mostly describing malfunctions like X-ray output failure and electrical or mechanical problems; no deaths and 3 injuries are reported. It has 3 open recalls for coolant level dropping enough to trigger overheating warnings and limit operation, and rare backup-mode boot after abrupt shutdown that may cancel treatment. There were 0 reports in the last 12 months versus 4 in the prior 12.

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
91
Deaths reported
0
Injuries reported
3
Recalls naming it
3

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 04056869010052), received between Jun 22, 2020 and Aug 5, 2025 — classified as 3 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Output Problem” (12 reports).

3 FDA recall records name this device's identifier, 3 still open.

68 other recalls cover devices cleared under the same FDA submission (K122644, K141574, 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 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, 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. 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-0968-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Output Problem12
  • Use of Device Problem11
  • Electrical /Electronic Property Problem9
  • Mechanical Problem9
  • No Apparent Adverse Event8
  • Radiation Output Failure7
  • Radiation Output Problem7
  • Connection Problem6

Patient problems

  • No Clinical Signs, Symptoms or Conditions78
  • No Known Impact Or Consequence To Patient5
  • Insufficient Information4
  • No Consequences Or Impact To Patient3
  • Bone Fracture(s)1
  • Crushing Injury1
  • Electric Shock1
  • Fall1

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING. DURING AN EMERGENCY PATIENT PROCEDURE, NO X RAY WAS POSSIBLE. THE PATIENT HAD TO BE RELOCATED TO COMPLETE THE PROCEDURE ON AN ALTERNATE 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 22714540 ↗
  • MalfunctionJan 10, 2025No Apparent Adverse Event; No Apparent Adverse Event

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. WHILE PERFORMING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY EXPOSURE WAS POSSIBLE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PROCEDURE WAS CONTINUED AND 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 21124914 ↗
  • MalfunctionDec 27, 2024Mechanical Jam; Mechanical Jam

    IT WAS REPORTED TO SIEMENS THAT AN ERROR OCCURRED WHILE USING THE ARTIS ZEE CEILING. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THEY RECEIVED AN ERROR MESSAGE, ¿PROXIMITY OR QS ERROR¿ WHICH CAUSED LIMITED STAND/TABLE MOVEMENT DURING 3D. THE PROCEDURE WAS CONTINUED AND FINISHED USING 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 INVESTIGATE THE REPORTED EVENT.

    Patient problems: Insufficient Information

    MAUDE report 21025561 ↗
  • MalfunctionNov 8, 2024Unexpected/Unintended Radiation Output; Unexpected/Unintended Radiation Output

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT X-RAY WAS UNINTENTIONALLY RELEASED. THE PROCEDURE WAS CONTINUED AND COMPLETED ON THE IMPERFECT 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 20639234 ↗
  • MalfunctionSep 11, 2024Radiation Output Problem; Radiation Output Failure; Radiation Output Problem; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. THE USER REPORTED THAT DURING AN EMERGENCY PATIENT PROCEDURE, X-RAY IMAGE WAS NOT AVAILABLE. 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 20189276 ↗
  • MalfunctionJul 2, 2024Unintended Movement; Unintended Movement

    SIEMENS BECAME AWARE OF AN UNINTENDED SYSTEM MOVEMENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING MACHINE. AFTER THE IMAGING EXAMINATION WAS COMPLETED, THE C-ARM MOVED WITHOUT GIVEN COMMAND AND CRASHED INTO A PATIENT ON A WHEELCHAIR. THERE ARE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ON-GOING; THEREFORE, THE EVENT IS REPORTED IN DOUBT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19656671 ↗
  • MalfunctionApr 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING UNIT. DURING AN EMERGENCY PATIENT PROCEDURE, THE SYSTEM WENT INTO THE BYPASS MODE. THE PROCEDURE WAS COMPLETED ON AN ALTERNATE SYSTEM. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. SIEMENS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 19054218 ↗
  • MalfunctionFeb 6, 2024Unintended Movement; Insufficient Device Problem Information; Unintended Movement; Insufficient Device Problem Information

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING. AFTER THE PATIENT PROCEDURE WAS COMPLETED AND WHILE THE PATIENT WAS BEING TRANSFERRED TO A BED, AN UNINTENTIONAL LATERAL TABLE MOVEMENT WAS REPORTED. 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 18652210 ↗
  • MalfunctionJan 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE UNIT TURNED OFF, WHICH RESULTED IN A TREATMENT DELAY. 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 18606624 ↗
  • InjuryDec 18, 2023Use of Device Problem; Use of Device Problem

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. THE PATIENT WAS LEFT UNINTENDED IN THE EXAM ROOM. IT WAS REPORTED THAT THE PATIENT FELL OFF THE TABLE APPROXIMATELY 1.2 METERS ( = 3.937 FEET) DOWN. THE PATIENT PASSED AWAY DUE TO THE SKULL INJURIES. ADDITIONAL INFORMATION WAS PROVIDED THAT THERE WAS NO EQUIPMENT FAILURE. A CAUSAL RELATION BETWEEN THE PATIENT DEATH AND THE MEDICAL DEVICE COULD NOT BE ESTABLISHED.

    Patient problems: Fall

    MAUDE report 18347843 ↗
  • MalfunctionSep 7, 2023Radiation Output Failure; Radiation Output Failure

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN EMERGENCY PROCEDURE, AN ERROR MESSAGE REGARDING THE X-RAY TUBE WAS DISPLAYED. FURTHERMORE, INTERVAL WARNING SOUND WAS HEARD AS WELL. THE PATIENT WAS RELOCATED TO A DIFFERENT HOSPITAL TO CONTINUE WITH THE PROCEDURE. THE 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 INVOLVED PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17699144 ↗
  • MalfunctionAug 3, 2023Use of Device Problem; Use of Device Problem

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. ACCORDING TO THE PROVIDED INFORMATION, THE USER PRESSED THE EMERGENCY POWER OFF (EPO) BUTTON WHEN THE PATIENT STARTED CODING DURING THE PROCEDURE. IT WAS COMMUNICATED TO SIEMENS THAT THE PATIENT PASSED AWAY. NO SYSTEM DEFECT COULD BE IDENTIFIED BY SIEMENS. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FOR THIS EVENT TO PROCEED WITH THE INVESTIGATION.

    Patient problems: Insufficient Information

    MAUDE report 17450254 ↗
  • MalfunctionJul 25, 2023Unintended Electrical Shock; Unintended Electrical Shock

    IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A PERSON RECEIVED AN ELECTRIC SHOCK DURING THE INSTALLATION OF A POWER CABLE. THERE WAS NO INDICATION OF ANY ADVERSE HEALTH EFFECTS ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17388218 ↗
  • MalfunctionSep 21, 2022Poor Quality Image; Output Problem; Poor Quality Image; Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. THE USER REPORTED ARTIFACTS ON FLUORO IMAGES DURING A PERK CHOLECYSTOSTOMY PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN UNLTRASOUND. 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 15462172 ↗
  • MalfunctionMay 3, 2022Poor Quality Image; Poor Quality Image

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED POOR IQ FLUORO. 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 14268514 ↗
  • MalfunctionMar 30, 2022Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. THE USER REPORTED THAT THE PB-LEAD GLASS COULD NOT BE FIXED IN THE UPPER BODY SUPPORT ARM OF THE MAVIG SHIELD. IF THE LEAD SHIELD DROPPED FROM ITS HOLD, THE POSSIBILITY EXISTS FOR INJURY TO THE PATIENT OR OPERATOR. 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 13949583 ↗
  • MalfunctionMar 11, 2022Computer Software Problem; Computer Software Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO IMAGE 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 13732638 ↗
  • MalfunctionMar 11, 2022Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. AT THE COMPLETION OF A PROCEDURE, THE CABLE CLAMPS BECAME DETACHED FROM THE CEILING AND NEARLY HIT THE PATIENT. 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 13732592 ↗
  • MalfunctionFeb 2, 2022Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE CABLE OF THE TABLE CONTROLLER (TCM) ATTACHED TO THE SLEEPER BECAME CAUGHT IN THE CEILING STAND. AS A RESULT, THE CABLE WAS BROKEN AND THE STAND COULD NO LONGER BE OPERATED. 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 13421493 ↗
  • MalfunctionFeb 1, 2022Connection Problem; Connection Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE DSA MACHINE SUDDENLY BEGAN LEAKING WATER FROM THE TUBE WATER COOLER. AS A RESULT, NO X-RAY RELEASE WAS POSSIBLE. 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 13412400 ↗
  • MalfunctionJan 5, 2022Radiation Output Failure; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE 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 13167563 ↗
  • MalfunctionDec 23, 2021No Flow; No Flow

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. THE USER REPORTED THAT THE DEVICE STOPPED WORKING DURING AN INTERVENTIONAL PROCEDURE. 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 13078373 ↗
  • MalfunctionDec 13, 2021Overheating of Device; Overheating of Device

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE SYSTEM COULD NOT PERFORM EXPOSURES AND AN FD TEMPERATURE TOO HIGH WARNING MESSAGE WAS DISPLAYED. 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 12982569 ↗
  • InjuryDec 13, 2021Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED INVOLVING THE ARTIS ZEE CEILING SYSTEM. IT WAS REPORTED THAT A MEMBER OF THE HOUSEKEEPING STAFF RECEIVED AN ELECTRIC SHOCK WHEN TOUCHING THE MONITOR. FURTHER INFORMATION WAS PROVIDED THAT THE AFFECTED PERSON WAS ADVISED TO RECEIVE AN ELECTROCARDIOGRAM (ECG). WE ARE UNAWARE OF ANY FURTHER IMPACT TO THE STATE OF HEALTH OF THE PERSON INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Patient problems: Electric Shock

    MAUDE report 12982568 ↗
  • MalfunctionDec 13, 2021Temperature Problem; Temperature Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE SYSTEM COULDN'T PERFORM EXPOSURES AND A TUBE HOT MESSAGE WAS DISPLAYED ON THE MONITOR. 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 12982566 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122644, K141574, K181407. One submission often covers many models, so check the product and lot details in each record.

  • Z-1645-2022 · Aug 10, 2022 · Open, Classified
    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Ar
  • 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-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-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-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-0975-2022 · Feb 23, 2022 · Open, Classified
    Artis Q ceiling, Model Number 10848281
  • 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-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

…and 53 more.

Other System, x-ray, tomography, computed devices

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Sources and updates

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