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Artis zeego 10280959Recalls & reported problems

Siemens Healthcare GmbH · Class 2

All models of Artis zeego (2)

Data updated Oct 16, 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 zeego is an interventional fluoroscopic X-ray system. The 24 reports mostly describe mechanical and X-ray output problems, including robot movement issues and X-ray becoming unavailable so procedures were finished on another system, and mention 1 death and 1 injury. There are 4 recalls, 3 open, involving low coolant blocking X-ray use and startup problems blocking movement or full operation, with 1 closed recall about blocked stand movement.

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
24
Deaths reported
1
Injuries reported
1
Recalls naming it
4

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04056869010083), received between Jul 16, 2020 and Aug 7, 2025 — classified as 1 death, 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

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

67 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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 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, 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. May 24, 2022Terminated

    It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.

    Z-1343-2022 · Root cause: Component design/selection · 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-0973-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Mechanical Problem6
  • No Apparent Adverse Event3
  • Output Problem3
  • Radiation Output Problem3
  • Electrical /Electronic Property Problem2
  • Insufficient Device Problem Information2
  • Radiation Output Failure2
  • Radiation Overexposure2

Patient problems

  • No Clinical Signs, Symptoms or Conditions21
  • Cardiac Arrest1
  • No Known Impact Or Consequence To Patient1
  • Radiodermatitis1

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 7, 2025Radiation Overexposure; Radiation Overexposure

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEEGO UNIT. SIEMENS RECEIVED INFORMATION THAT THE DOSE ON AN INTERVENTION RADIOLOGIST'S BADGE WAS SIGNIFICANTLY HIGHER IN (B)(6) 2024 THAN IN OTHER MONTHS. NO INFORMATION ON THE RECORDED DOSE WAS PROVIDED. NO HEALTH CONSEQUENCES WERE REPORTED FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22740064 ↗
  • MalfunctionJul 25, 2024Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED ON THE ARTIS ZEEGO UNIT. DURING AN EMERGENCY PATIENT PROCEDURE, THE AUTOMATIC ROBOT DRIVE COULD NOT BE ACTIVATED RESTRICTING TABLE MOTION. THE PATIENT HAD TO BE RELOCATED, AND THE PROCEDURE WAS COMPLETED ON AN ALTERNATE UNIT. SIEMENS IS UNAWARE OF ANY ADVERSE HEALTH IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19828643 ↗
  • MalfunctionFeb 26, 2024Unintended Movement; Unintended Movement

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. THE USER REPORTED AN UNINTENDED ROBOT MOVEMENT DURING SYSTEM USAGE. NO COLLISION WITH OTHER OBJECTS HAS BEEN REPORTED. WE HAVE NO INDICATIONS OF ADVERSE EFFECTS ON THE HEALTH STATUS OF PATIENTS, USERS OR THIRD PARTIES. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18778153 ↗
  • MalfunctionJul 19, 2022Output Problem; Radiation Output Problem; Radiation Output Failure; Output Problem; Radiation Output Problem; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING SYSTEM START-UP FOR AN EMERGENCY PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS AVAILABLE 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 SWEDEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15052942 ↗
  • MalfunctionJul 18, 2022Output Problem; Radiation Output Problem; Radiation Output Failure; Output Problem; Radiation Output Problem; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS AVAILABLE AND AN EXPOSURE WAS NOT 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. THE REPORTED EVENT OCCURRED IN NORWAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15045074 ↗
  • MalfunctionJun 22, 2022Overheating of Device; Overheating of Device

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS AVAILABLE AND AN EXPOSURE WAS NOT 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 14771731 ↗
  • MalfunctionJun 21, 2022Mechanical Jam; Mechanical Jam

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE SYSTEM WAS DRIVING WITH SLOW SPEED. AS A RESULT, FULL RESTART OF THE SYSTEM CAUSED A DELAY OF 20 MINUTES. 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 14759310 ↗
  • DeathJan 24, 2022Optical Problem; Optical Problem

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. THE CUSTOMER REPORTED NO IMAGE ON THE LARGE DISPLAY AFTER SYSTEM START UP. FURTHER INFORMATION WAS PROVIDED THAT THE PATIENT PASSED AWAY. AT THIS TIME, THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE DEATH OF THE PATIENT AND THE SYSTEM BEHAVIOR. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Patient problems: Cardiac Arrest

    MAUDE report 13333216 ↗
  • MalfunctionOct 19, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO 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 12655374 ↗
  • MalfunctionSep 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SYNGO.X WORKPLACE ON AN ARTIS ZEEGO SYSTEM. THE USER REPORTED THAT THE CT PORTION OF THE ARTIS ZEEGO X-RAY SYSTEM WAS NOT WORKING. THE OR TEAM HAD TO TURN THE MACHINE OFF AND ON THREE TIMES BEFORE THE MACHINE WOULD TURN ON. THE USER REPORTED THAT THIS HAS HAPPENED OVER THE PAST FEW DAYS. 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 12445503 ↗
  • MalfunctionSep 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO 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 12438925 ↗
  • MalfunctionSep 8, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE FLAT PANEL CANNOT BE MOVED UP AND 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 12438921 ↗
  • MalfunctionSep 3, 2021Output Problem; Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, AN ERROR MESSAGE "TUBE HOT" WAS DISPLAYED TO THE USER. 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 (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12421324 ↗
  • MalfunctionJul 20, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE SYSTEM STOPPED MOVING AND THE USER SAW THE COLLISION CONTROL DEACTIVATED 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 12195585 ↗
  • MalfunctionJun 9, 2021No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. ACCORDING TO THE USER, THE SYSTEM BEHAVED UNEXPECTEDLY AND BLOOD FLOWED INTO THE TUBE COVER. THE EMERGENCY BUTTON WAS PRESSED AND THE SYSTEM WAS 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 11966530 ↗
  • InjuryMay 19, 2021Radiation Overexposure; Radiation Overexposure

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED FOLLOWING EXAMINATION ON THE ARTIS ZEEGO SYSTEM. FOLLOWING AN INTERVENTIONAL PROCEDURE ON (B)(6) 2020, A PATIENT SUFFERED AN UNCONFIRMED SKIN INJURY OF RADIODERMATITIS. INVESTIGATION AT THE TIME OF THE EVENT DID NOT CONFIRM AN ABNORMAL RADIATION DOSE. SIEMENS HAS BECOME AWARE OF NEW INFORMATION ON MAY 17, 2021, THAT SUGGESTS THE POSSIBILITY OF AN EXCESSIVELY HIGH RADIATION DOSE. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Patient problems: Radiodermatitis

    MAUDE report 11847394 ↗
  • MalfunctionApr 27, 2021Radiation Output Problem; Radiation Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED AN IMAGE PROBLEM. 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 11730821 ↗
  • MalfunctionMar 5, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO ACQUISITION 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 11421195 ↗
  • MalfunctionFeb 16, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. THE USER REPORTED THAT TABLE WOBBLING MADE A PROCEDURE DIFFICULT. 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 11331636 ↗
  • MalfunctionFeb 10, 2021No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING A PROCEDURE, THE USER REPORTED THAT THE ROBOT-ASSISED C-ARM STOPPED WHEN IT WAS RETRACTED. THIS TRIGGERED A COLLISION ALARM AND NO FURTHER 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 11307976 ↗
  • MalfunctionFeb 9, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO STAND 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 11300280 ↗
  • MalfunctionOct 7, 2020Computer Software Problem; Computer Software Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED PROBLEMS WITH CALIBRATION, AND THE TEXT "NOT CALIBRATED" WAS DISPLAYED OVER ALL OF THE IMAGES. 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 10641747 ↗
  • MalfunctionSep 18, 2020Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE C-ARM WOULD NOT MOVE. 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 10553559 ↗
  • MalfunctionJul 16, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED TO SIEMENS THAT AN ERROR OCCURRED WHILE USING THE ARTIS ZEEGO. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTS "STAND MOVEMENT STOPS". 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 OF THE REPORTED EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10282198 ↗

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. 1084835
  • 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-0975-2022 · Feb 23, 2022 · Open, Classified
    Artis Q ceiling, Model Number 10848281
  • Z-0969-2022 · Feb 23, 2022 · Open, Classified
    Artis zee multi-purpose, Model Number 10094139
  • Z-0971-2022 · Feb 23, 2022 · Open, Classified
    Artis zee floor MN, Model Number 10094142
  • Z-0976-2022 · Feb 23, 2022 · Open, Classified
    Artis Q biplane, Model Number 10848282
  • Z-0978-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen floor, Model Number 10848353
  • Z-0972-2022 · Feb 23, 2022 · Open, Classified
    Artis zee biplane MN, Model Number 10094143
  • Z-0970-2022 · Feb 23, 2022 · Open, Classified
    Artis zee biplane, Model Number 10094141
  • Z-0980-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen biplane, Model Number 10848355
  • 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-0967-2022 · Feb 23, 2022 · Open, Classified
    Artis zee floor, Model Number 10094135
  • Z-0297-2022 · Oct 20, 2021 · Terminated
    Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137

…and 52 more.

Other Interventional fluoroscopic x-ray system devices

All Interventional fluoroscopic x-ray system devices →

Sources and updates

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