ARTIS pheno 10849000Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 04056869046877), received between Jun 24, 2020 and Feb 10, 2026 — classified as 2 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Unintended Collision” (9 reports).

14 FDA recall records name this device's identifier, 13 still open.

18 other recalls cover devices cleared under the same FDA submission (K163286, K201156, K220409, K230949, K241572, K254173); 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.

Recalls naming this device

1. Mar 12, 2026Class IIOpen, Classified

   During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

   Z-1814-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

2. Mar 10, 2026Class IIOpen, Classified

   During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.

   Z-1653-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

3. Mar 9, 2026Class IIOpen, Classified

   During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

   Z-2205-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

4. Aug 12, 2025Class IIOpen, Classified

   Limited system movements after startup .

   Z-2529-2025 · Root cause: Software design · Recall details · FDA record ↗

5. May 15, 2025Class IIOpen, Classified

   In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

   Z-2019-2025 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

6. Feb 2, 2023Class IIOpen, Classified

   If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.

   Z-1498-2023 · Root cause: Software design · Recall details · FDA record ↗

7. Feb 2, 2023Class IIOpen, Classified

   In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

   Z-1311-2023 · Root cause: Software design · Recall details · FDA record ↗

8. Dec 16, 2022Class IIOpen, Classified

   Mechanical connection between the tabletop and table base may be lost.

   Z-0956-2023 · Root cause: Device Design · Recall details · FDA record ↗

9. Sep 20, 2022Class IIOpen, Classified

   Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

   Z-0119-2023 · Root cause: Software design · Recall details · FDA record ↗

10. Aug 10, 2022Class IIOpen, 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-1646-2022 · Root cause: Device Design · Recall details · FDA record ↗

11. Jun 10, 2022Class IIOpen, Classified

    A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.

    Z-1294-2022 · Root cause: Process control · Recall details · FDA record ↗

12. Feb 25, 2022Class IIOpen, Classified

    After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.

    Z-1339-2022 · Root cause: Software design · Recall details · FDA record ↗

13. Feb 25, 2022Class IIOpen, Classified

    Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed

    Z-0987-2022 · Root cause: Software Design Change · Recall details · FDA record ↗

14. Oct 12, 2021Class IITerminated

    Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

    Z-0515-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Display or Visual Feedback Problem; Activation Failure

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO UNIT. DURING AN INTERVENTIONAL PATIENT PROCEDURE, NO TABLE MOVEMENTS WERE AVAILABLE. ADDITIONAL INFORMATION WAS PROVIDED TO SIEMENS STATING THAT THE PATIENT PASSED AWAY. IT IS UNCLEAR WHETHER THE DEVICE PERFORMANCE CONTRIBUTED TO THE PATIENT¿S DEATH. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION AND IS CONDUCTING AN INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 24305222 ↗
• MalfunctionJan 20, 2026Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO UNIT. WHEN PATIENT WAS IN TRENDELENBURG CRADLE POSITION RIGHT SIDE DOWN, THE USER WAS TRYING TO SWITCH BEDS BUT AT BREAKPOINT THE BED SLIPPED OUT AND THE PATIENT FELL TO THE FLOOR. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall

  MAUDE report 24116008 ↗
• MalfunctionJan 16, 2026Radiation Output Problem

  SIEMENS HEALTHINEERS WAS INFORMED BY ITS SERVICE ORGANIZATION THAT THE SYSTEM COULD NOT BE POWERED ON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ISSUE OCCURRED DURING AN EMERGENCY PROCEDURE. THE PROCEDURE WAS PERFORMED BY RELOCATING THE PATIENT TO ANOTHER SYSTEM. SIEMENS HEALTHINEERS HAS NOT RECEIVED ANY INDICATION OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095687 ↗
• MalfunctionAug 1, 2025Mechanical Problem; Mechanical Problem

  SIEMENS WAS INFORMED ON (B)(6) 2025 BY ITS SERVICE ORGANIZATION THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS PHENO. THE DISPLAY CEILING SUSPENSION (DCS) DETACHED FROM THE CEILING MOUNTING. THE ISSUE HAPPENED BEFORE THE SCHEDULED PROCEDURE AND CAUSED THE PROCEDURE TO BE CANCELED. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT OR OTHER PERSONS. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22685610 ↗
• MalfunctionJul 28, 2025Computer Software Problem; Computer Software Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. SYSTEM MOVEMENTS WERE BLOCKED AT THE UNIT STARTUP. TO THE PROBLEM, THE ROBOT WAS RESTARTED AS PART OF SERVICE ACTIVITY. NO HEALTH CONSEQUENCES WERE REPORTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636844 ↗
• MalfunctionJul 28, 2025Computer Software Problem; Computer Software Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. THE MACHINE WAS POWERED UP; HOWEVER, SYSTEM MOVEMENTS WERE BLOCKED. TO RESOLVE THE PROBLEM, FILES WERE RELOADED ON THE ROBOT, AND THE SYSTEM WAS RESTARTED AS PART OF SERVICE ACTIVITY. NO HEALTH CONSEQUENCES WERE REPORTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636516 ↗
• MalfunctionJul 28, 2025Computer Software Problem; Computer Software Problem

  SIEMENS WAS INFORMED THAT WHILE PERFORMING SERVICE ACTIVITIES ON THE ARTIS PHENO UNIT, THE SYSTEM WAS SHUT DOWN AS NORMAL SEQUENCE VIA THE IMAGE VISUALIZATION SYSTEM (IVS). HOWEVER, WHEN TURNING THE MACHINE BACK ON, SYSTEM MOVEMENTS WERE BLOCKED. NO HEALTH CONSEQUENCES WERE REPORTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22633001 ↗
• MalfunctionJul 24, 2025Computer Software Problem; Computer Software Problem

  WAS SHUT DOWN AS NORMAL SEQUENCE VIA THE IMAGE VISUALIZATION SYSTEM (IVS) BUT WHEN TURNING ON THE SYSTEM THE NEXT TIME SYSTEM MOVEMENTS WERE BLOCKED. NO HEALTH CONSEQUENCES WERE REPORTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586812 ↗
• InjuryJun 30, 2025Positioning Problem; Positioning Problem

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. DURING PATIENT TRANSFER TO THE TABLE, THE HEAD SIDE END OF THE MATTRESS SLID OVER THE EDGE OF THE TABLE. THE PATIENT WENT TO PLACE HAND DOWN ON THE TABLE WHILE BEING POSITIONED, BUT DUE TO THE MATTRESS NOT BEING SECURED AND HANGING OFF THE EDGE OF THE TABLE, THE PATIENT SLIPPED AND FELL. THE FALL RESULTED IN THE PATIENT RECEIVING A HEAD INJURY. A MEDICAL EXAMINATION OF THE PATIENT WAS PERFORMED; AFTER MEDICAL DIAGNOSIS NO HEALTH CONSEQUENCE WAS IDENTIFIED.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358328 ↗
• MalfunctionMar 31, 2025Radiation Output Failure; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE USING THE ARTIS PHENO. DURING AN EMERGENCY PROCEDURE, THE USER STATED THAT THERE WAS NO X-RAY PROTOCOL POSSIBLE, ONLY THE DEFAULT EXAM PROTOCOL WAS VISIBLE. 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 HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729338 ↗
• MalfunctionFeb 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, SYSTEM MOVEMENTS WERE BLOCKED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATIVE 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 21356102 ↗
• MalfunctionJan 29, 2025Radiation Output Problem; Radiation Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE USING THE ARTIS PHENO. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE. THE SYSTEM REPORTED A DEFECTIVE MESSAGE ERROR FOR THE MICRO FOCUS, THE SMALL FOCUS AND THE LARGE FOCUS. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262987 ↗
• MalfunctionDec 30, 2024Unintended Movement; Unintended Movement

  SIEMENS BECAME AWARE OF AN ADVERSE EVENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. PRIOR TO THE PROCEDURE DURING THE PATIENT TRANSFER, THE PATIENT FELL OFF THE TABLE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM. THE DETAILS OF THE INCIDENT ARE UNCLEAR; SIEMENS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21035435 ↗
• MalfunctionNov 15, 2024Device Handling Problem; Device Handling Problem

  IT WAS REPORTED TO THE MANUFACTURER BY ITS SERVICE ORGANIZATION THAT AN EVENT OCCURRED DURING PATIENT TRANSPORT. THE LEFT SIDE TABLE RAIL FELL OFF AND HIT THE TECHNICIAN'S BIG TOE AND RESULTED IN A BREAK. A CUSTOMER SERVICE ENGINEER HAS BEEN DISPATCHED FOR AN ON-SITE VISIT TO DETERMINE WHY THE SIDE RAIL FELL OFF AND TO REPAIR, AS NEEDED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 20694856 ↗
• MalfunctionOct 28, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THE STAND AND TABLE DID 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 20543018 ↗
• MalfunctionOct 15, 2024Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, A COLLISION OCCURRED BETWEEN THE C-ARM AND THE TABLE. THE PROCEDURE WAS CONTINUED AND COMPLETED. 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 20449429 ↗
• MalfunctionMay 8, 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 POTENTIAL COLLISION OF THE ARTIS PHENO SYSTEM. THE ACCIDENT OCCURRED DURING CUSTOMER UTILIZATION. THE PROVIDED PICTURES SHOW DAMAGE TO THE C-ARM COVER, WHERE THE FLAT DETECTOR IS ATTACHED. THE MECHANICAL STRUCTURE OF THE SYSTEM WAS NOT AFFECTED. SIEMENS HAS REQUESTED ADDITIONAL DETAILS ABOUT THE COLLISION.

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

  MAUDE report 19268403 ↗
• MalfunctionMar 20, 2024Unintended Collision; Unintended Collision

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO UNIT. DURING A PATIENT PROCEDURE, AN UNINTENDED COLLISION OF THE C-ARM AND THE PATIENT TABLE OCCURRED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED ON THE SAME SYSTEM. DAMAGES TO THE TABLE COVER WERE REPORTED AS A RESULT OF THIS COLLISION. 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 18939799 ↗
• MalfunctionMar 12, 2024Unintended Collision; Unintended Collision

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO UNIT. THE ROBOTIC C-ARM COLLIDED WITH THE PATIENT TABLE BASE. WE HAVE NO INDICATIONS OF ADVERSE EFFECTS ON THE HEALTH STATUS OF PATIENTS, USERS OR THIRD PARTIES. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION ABOUT THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886181 ↗
• MalfunctionJan 16, 2024Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. A PATIENT WITH A RAPTURED AORTA WAS ADMITTED TO THE FACILITY, WHERE AN IMMEDIATE EMERGENCY PROCEDURE ON THE ARTIS PHENO WAS STARTED SIMULTANEOUSLY WITH THE CARDIOPULMONARY RESUSCITATION (CPR) PROCEDURE. AFTER SEVERAL MINUTES OF PERFORMING THE CPR STANDING BETWEEN THE TABLE AND THE DETECTOR, THE USER ATTEMPTED TO MOVE THE PHENO C-ARM AWAY FROM THE TABLE TO GAIN BETTER ACCESS TO THE PATIENT. THIS RESULTED IN ACTIVATION OF THE SYSTEM COLLISION SENSORS AND NO SYSTEM MOVEMENTS WERE AVAILABLE. THE USER THEN MOVED THE PATIENT TABLE AWAY FROM THE C-ARM TO CONTINUE WITH THE CPR. HOWEVER, IT WAS REPORTED THAT THE PATIENT PASSED AWAY DURING THE CPR. THE RELATIONSHIP BETWEEN THE SYSTEM FAILURE AND THE PATIENT DEATH IS UNKNOWN AT THIS POINT IN TIME. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FOR THIS EVENT.

  Patient problems: Cardiovascular Dysfunction/Insufficiency

  MAUDE report 18520375 ↗
• MalfunctionJan 16, 2024Unintended Collision; Unintended Collision

  SIEMENS BECAME AWARE OF ON INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. AN UNINTENDED C-ARM COLLISION OCCURRED WITH THE TABLE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE COLLISION RESULTED IN MECHANICAL DAMAGE OF THE C-ARM. 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 18516427 ↗
• MalfunctionJan 9, 2024Unintended Collision; Unintended Collision

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. DURING A ROUTINE PREOPERATIVE SYSTEM PREPARATION, COMMUNICATION BETWEEN THE DIGITAL SUBSTRUCTION ANGIOGRAPHY (DSA) AND THE SLIDE GANTRY WAS LOST. THIS FAILURE RESULTED IN A COLLISION BETWEEN THE UNIT AND THE SLIDE GANTRY. WE ARE UNAWARE ON ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PERSONS, HOWEVER, THIS INCIDENT RESULTED IN A PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476340 ↗
• MalfunctionJan 9, 2024Unintended Collision; Use of Device Problem; Unintended Collision; Use of Device Problem

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. PRIOR TO AN EXAM DURING A ROUTINE EQUIPMENT CHECK, THE TECHNICIANS STARTED THE UNIT AND THE C-ARM COLLIDED WITH THE MAQUET TABLE HEAD SUPPORT. WE ARE UNAWARE ON ANY ADVERSE EFFECTED ON THE HEALTH STATUS OF THE INVOLVED PERSONS, HOWEVER, THIS INCIDENT RESULTED IN PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475318 ↗
• MalfunctionOct 27, 2023Radiation Output Failure; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS PHENO UNIT. DURING AN EMERGENCY PROCEDURE, THE USER WAS UNABLE TO PERFORM X-RAY EXPOSURE. 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 18021687 ↗
• MalfunctionSep 13, 2023Radiation Output Failure; Radiation Output Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. DURING AN EMERGENCY PROCEDURE, NO X-RAY RELEASE WAS AVAILABLE. THE PATIENT HAD TO BE MOVED TO COMPLETE THE PROCEDURE ON AN ALTERNATE UNIT, HOWEVER, THE PROCEDURE WAS DELAYED. THE PATIENT SUBSEQUENTLY EXPIRED. THE RELATIONSHIP BETWEEN THE SYSTEM FAILURE AND THE PATIENT DEATH IS UNKNOWN AT THIS POINT IN TIME. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17737143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163286, K201156, K220409, K230949, K241572, K254173. One submission often covers many models, so check the product and lot details in each record.

• Z-2643-2026 · May 20, 2026 · Open, Classified
  ARTIS icono floor. Model Number: 11327700.
• Z-2641-2026 · May 20, 2026 · Open, Classified
  ARTIS icono biplane. Model Number: 11327600.
• Z-2642-2026 · May 20, 2026 · Open, Classified
  ARTIS icono ceiling. Model Number: 11328100.
• Z-2206-2026 · Mar 9, 2026 · Open, Classified
  ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray
• Z-2021-2025 · May 15, 2025 · Open, Classified
  interventional fluoroscopic x-ray system
• Z-2022-2025 · May 15, 2025 · Open, Classified
  interventional fluoroscopic x-ray system
• Z-2020-2025 · May 15, 2025 · Open, Classified
  interventional fluoroscopic x-ray system
• Z-2361-2023 · Jun 19, 2023 · Open, Classified
  ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
• Z-2029-2021 · May 27, 2021 · Open, Classified
  ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
• Z-1497-2021 · Mar 19, 2021 · Terminated
  Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems develop
• Z-2108-2020 · Apr 22, 2020 · Terminated
  ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic ima
• Z-1340-2020 · Jan 24, 2020 · Terminated
  ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplan
• Z-0807-2020 · Dec 20, 2019 · Terminated
  Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional pr
• Z-1905-2019 · Jun 6, 2019 · Terminated
  Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
• Z-3190-2018 · Jul 29, 2018 · Terminated
  ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

…and 3 more.