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Artis zee biplane 10094141Recalls & 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

The Artis zee Biplane is a Siemens X-ray angiography system for imaging blood vessels. Its 62 adverse event reports mostly describe imaging interrupted mid-procedure — dark or missing images, unresponsive screens, reboots — sometimes forcing treatment onto another system. No deaths and 2 injuries were reported. Three open recalls include two, in February 2022 and March 2024, about low coolant levels overheating the X-ray tube, and one from December 2022 about the system booting only into backup mode after a sudden shutdown.

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
63
Deaths reported
0
Injuries reported
2
Recalls naming it
3

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 04056869010069), received between Jul 1, 2020 and Aug 28, 2026 — classified as 2 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Radiation Output Problem” (8 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: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 1 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: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
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-0970-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Radiation Output Problem8
  • Insufficient Device Problem Information7
  • Mechanical Problem7
  • Radiation Output Failure6
  • Use of Device Problem5
  • Electrical /Electronic Property Problem4
  • Optical Problem3
  • Output Problem3

Patient problems

  • No Clinical Signs, Symptoms or Conditions60
  • Hair Loss1
  • Hemorrhage/Blood Loss/Bleeding1
  • Insufficient Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 28, 2026Activation Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50497556 ↗
  • MalfunctionAug 18, 2026Insufficient Device Problem Information

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50298043 ↗
  • MalfunctionOct 21, 2025Radiation Output Failure; Radiation Output Failure

    SIEMENS BECAME OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE UNIT. DURING AN EMERGENCY CATHETERIZATION PROCEDURE, FLUOROSCOPY IMAGING BECAME UNAVAILABLE. THE PATIENT HAD TO BE MOVED 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 23348063 ↗
  • MalfunctionAug 12, 2025No Device Output; Insufficient Device Problem Information; No Device Output; Insufficient Device Problem Information

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, A TOTAL SYSTEM OUTAGE OCCURRED. THE PATIENT WAS RELOCATED TO ANOTHER HOSPITAL FOR FURTHER MEDICAL TREATMENT. 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 22786476 ↗
  • MalfunctionJul 17, 2025Computer Software Problem; Use of Device Problem; Computer Software Problem; Use of Device Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THE C-ARM PROGRAM MENU DID NOT APPEAR WHEN THE PROGRAM BUTTON ON THE ARM WAS PRESSED. 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 TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22529436 ↗
  • MalfunctionJun 24, 2025Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem; Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem

    SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. WHILE PREPARING A PATIENT FOR A PROCEDURE, THE PATIENT FELL OFF THE TABLE. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. THE PROCEDURE WAS CONTINUED AND FINISHED ON THE SAME UNIT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22319413 ↗
  • MalfunctionMar 18, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

    IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE USING THE ARTIS ZEE BIPLANE. DURING AN EMERGENCY PROCEDURE, THE USER STATED THAT PATIENT REGISTRATION WAS NOT POSSIBLE AND THAT THE LARGE DISPLAY WAS DARK. THE SYSTEM WAS REBOOTED SEVERAL TIMES AND STILL DID NOT COME TO READY STATE. 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 21633691 ↗
  • MalfunctionJan 7, 2025Poor Quality Image; Insufficient Device Problem Information; Radiation Output Problem; Poor Quality Image; Insufficient Device Problem Information; Radiation Output Problem

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. WHILE PERFORMING A FLUOROSCOPY PROCEDURE ON A PATIENT, THE OBTAINED IMAGES WERE DARK. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS RELOCATED TO A DIFFERENT MEDICAL FACILITY DUE TO THIS FAILURE. 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 21092694 ↗
  • MalfunctionSep 17, 2024Radiation Output Problem; Radiation Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE OF A PATIENT IN CRITICAL CONDITION, THE USER REPORTED THAT X-RAY COULD NOT BE RELEASED DURING ROADMAP. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING. 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 20235321 ↗
  • MalfunctionApr 23, 2024Defective Component; Defective Component

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATION THE ARTIS ZEE BIPLANE UNIT. DURING AN EMERGENCY PROCEDURE, THE EXAMINATION CONTROL CONSOLE WOULD NOT REACT TO THE OPERATOR¿S TOUCH. 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 19168619 ↗
  • MalfunctionFeb 2, 2024Insufficient Device Problem Information; Activation Failure; Insufficient Device Problem Information; Activation Failure

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE USER WAS UNABLE TO MOVE THE STAND TO EITHER A OR B PLANE. THE PATIENT HAD TO BE MOVED AND THE PROCEDURE WAS 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 18630890 ↗
  • InjuryDec 6, 2023Poor Quality Image; Use of Device Problem; Poor Quality Image; Use of Device Problem

    SIEMENS HEALTHINEERS WAS MADE AWARE OF AN IMAGE QUALITY ISSUE WITH THE ARTIS ZEE BIPLANE SYSTEM. IT WAS STATED THAT THE PATIENT SUFFERED AN INTRACRANIAL HEMORRHAGE. HOWEVER, THE PATIENT LEFT THE LAB IN STABLE CONDITION. CLARIFICATION REGARDING THE DETAILS OF THIS EVENT HAVE BEEN REQUESTED BUT HAVE NOT BEEN RECEIVED BY SIEMENS HEALTHINEERS AS OF THE DATE OF THIS REPORT.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 18273701 ↗
  • MalfunctionAug 28, 2023Radiation Output Failure; Radiation Output Failure

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE SYSTEM DISPLAYED A COOLING UNIT ERROR, AND NO X-RAY RELEASE WAS AVAILABLE. THE PATIENT HAD TO BE 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 PERSONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17632461 ↗
  • MalfunctionAug 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    SIEMENS WAS INFORMED ABOUT AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, A CEILING SUSPENDED LEAD RADIATION SHIELD MANUFACTURED BY A THIRD PARTY ¿ MAVIG - FELL DOWN. THE PROCEDURE WAS CONTINUED AND COMPLETED ON THE SAME UNIT. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING. THEREFORE, THE EVENT IS REPORTED IN DOUBT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17583847 ↗
  • MalfunctionNov 18, 2022Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. THE USER REPORTED ROADMAP SCENES NOT BEING CLEAR DURING AN EMERGENCY NEUROLOGY PROCEDURE. THE PATIENT HAD TO BE MOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON AN ALTERNATE SYSTEM. THERE IS NO REPORT OF 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 15824878 ↗
  • MalfunctionJul 6, 2022Output Problem; Radiation Output Failure; Output Problem; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE. THE X-RAY ABORTED DUE TO PLANE B BEING OUT-OF-ORDER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON AN ALTERNATE SYSTEM. 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. THE REPORTED EVENT OCCURRED IN JAPAN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14931771 ↗
  • MalfunctionApr 1, 2022Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. THE CUSTOMER REPORTS THAT THE PLASTIC COLLIMATOR COVER FELL OFF WHEN IT FLIPS UPSIDE DOWN. THE POSSIBILITY EXISTS THAT THE COVER COULD FALL INTO THE AREA OF SURGERY. 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 13977317 ↗
  • MalfunctionMar 2, 2022Patient Data Problem; Patient Data Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. THE USER REPORTED THAT PATIENT DATA MIXED UP OCCURRED. 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 13652688 ↗
  • MalfunctionFeb 23, 2022Radiation Output Failure; Radiation Output Failure

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO MORE 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 13583468 ↗
  • MalfunctionJan 20, 2022Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. THE USER REPORTED THAT A PATIENT WAS ON THE TABLE UNDER GENERAL ANESTHETIC FOR AN INTRACRANIAL ANEURYSM PROCEDURE WHEN THE ERROR OCCURRED. THE C-ARM BASE ROTATION WAS NOT LOCKING INTO POSITION AND THE SYSTEM WAS DISPLAYING A MANUAL IMAGE ROTATION ACTIVE MESSAGE. THE PLANE A STAND WAS NOT MOVING UNDER AUTOMATIC RUNS AROUND THE BASE ROTATION AXLE. THE PATIENT COULD NOT BE TRANSFERRED TO AN ALTERNATE SYSTEM, THEREFORE, THE PROCEDURE WAS ABORTED AND THE PATIENT WAS WOKEN UP. 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 13305237 ↗
  • MalfunctionDec 20, 2021No Display/Image; No Display/Image

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THE LARGE DISPLAY WAS DARK AND THE SYSTEM WENT INTO 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. 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 13042747 ↗
  • MalfunctionDec 13, 2021No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE SYSTEM WENT INTO 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. 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 12982563 ↗
  • MalfunctionDec 1, 2021Mechanical Problem; Mechanical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE 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 12908097 ↗
  • MalfunctionNov 30, 2021Optical Problem; Optical Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED IMAGE ARTIFACTS ON PLANE A. 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 12891529 ↗
  • MalfunctionNov 30, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE BIPLANE SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT IMAGING 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 12890966 ↗

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-0980-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen biplane, Model Number 10848355
  • Z-0971-2022 · Feb 23, 2022 · Open, Classified
    Artis zee floor MN, Model Number 10094142
  • Z-0967-2022 · Feb 23, 2022 · Open, Classified
    Artis zee floor, Model Number 10094135
  • Z-0976-2022 · Feb 23, 2022 · Open, Classified
    Artis Q biplane, Model Number 10848282
  • 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-0977-2022 · Feb 23, 2022 · Open, Classified
    Artis Q zeego, Model Number 10848283
  • Z-0969-2022 · Feb 23, 2022 · Open, Classified
    Artis zee multi-purpose, Model Number 10094139
  • Z-0974-2022 · Feb 23, 2022 · Open, Classified
    Artis Q floor, Model Number 10848280
  • Z-0979-2022 · Feb 23, 2022 · Open, Classified
    Artis Q.zen ceiling, Model Number 10848354
  • Z-0975-2022 · Feb 23, 2022 · Open, Classified
    Artis Q ceiling, Model Number 10848281
  • Z-0968-2022 · Feb 23, 2022 · Open, Classified
    Artis zee ceiling, Model Number 10094137
  • Z-0972-2022 · Feb 23, 2022 · Open, Classified
    Artis zee biplane MN, Model Number 10094143

…and 53 more.

Other System, x-ray, angiographic devices

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Sources and updates

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