ARTIS icono floor 11327700Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04056869149325), received between Aug 21, 2020 and Apr 14, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 reports).

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

9 other recalls cover devices cleared under the same FDA submission (K190768, K220432, K230950, 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. May 20, 2026Class IIOpen, Classified

   Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

   Z-2643-2026 · Root cause: Software design · 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-2206-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

4. 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-2022-2025 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

5. Jun 26, 2024Class IIOpen, Classified

   A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

   Z-2241-2024 · Root cause: Software design · Recall details · FDA record ↗

6. Jun 26, 2024Class IIOpen, Classified

   A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

   Z-2240-2024 · Root cause: Software design · Recall details · FDA record ↗

7. Jun 26, 2024Class IIOpen, Classified

   A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

   Z-2242-2024 · Root cause: Software design · Recall details · FDA record ↗

8. Jun 19, 2023Class IIOpen, Classified

   Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

   Z-2360-2023 · Root cause: Process control · Recall details · FDA record ↗

9. Jun 19, 2023Class IIOpen, Classified

   Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

   Z-2361-2023 · Root cause: Process control · Recall details · FDA record ↗

10. 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 ↗

11. 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-1647-2022 · Root cause: Device Design · Recall details · FDA record ↗

12. Apr 11, 2022Class IIOpen, Classified

    if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

    Z-1246-2022 · Root cause: Device Design · Recall details · FDA record ↗

13. 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 ↗

14. 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-0986-2022 · Root cause: Software Design Change · Recall details · FDA record ↗

15. 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-0517-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 14, 2026Computer Software Problem; Activation Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. PRIOR TO THE START OF AN INTERVENTIONAL PATIENT PROCEDURE, IT WAS DETERMINED THAT STAND MOVEMENTS WERE NOT POSSIBLE, AND A STAND/TABLE ERROR MESSAGE WAS DISPLAYED TO THE USER. AS A RESULT, THE OPERATOR WAS UNABLE TO PROCEED WITH THE PROCEDURE, WHICH WAS CANCELED. 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 24875562 ↗
• MalfunctionApr 14, 2026Computer Software Problem; Activation Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. PRIOR TO THE START OF AN INTERVENTIONAL PATIENT PROCEDURE, IT WAS DETERMINED THAT STAND MOVEMENTS WERE NOT POSSIBLE, AND A STAND/TABLE ERROR MESSAGE WAS DISPLAYED TO THE USER. AS A RESULT, THE OPERATOR WAS UNABLE TO PROCEED WITH THE PROCEDURE, WHICH WAS CANCELED. 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 24875167 ↗
• MalfunctionApr 10, 2026Mechanical Jam

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR. STAND MOVEMENTS WERE NOT POSSIBLE AND A STAND/TABLE ERROR WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839824 ↗
• MalfunctionApr 9, 2026No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR. STAND MOVEMENTS WERE NOT POSSIBLE AND A STAND/TABLE ERROR WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24833064 ↗
• MalfunctionApr 9, 2026No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR. STAND TEST WAS NOT POSSIBLE AS STAND MOVEMENTS WERE NOT POSSIBLE AND A STAND/TABLE ERROR WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832696 ↗
• MalfunctionJan 12, 2026Radiation Overexposure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. THE RADIATION DOSE APPLIED TO THE PATIENT DURING AN INTERVENTIONAL PROCEDURE WAS REPORTED TO BE HIGHER THAN EXPECTED. THE PROCEDURE WAS CONTINUED AND COMPLETED ON THE SAME 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 24037345 ↗
• MalfunctionJan 9, 2026Activation Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE UNIT WOULD NOT START, WHICH LED TO A DELAY. 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 24022777 ↗
• MalfunctionDec 19, 2025Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  SIEMENS WAS INFORMED ABOUT A SYSTEM MALFUNCTION THAT OCCURRED ON THE ARTIS ICONO FLOOR UNIT. ADDITIONAL INFORMATION WAS PROVIDED THAT THE ISSUE OCCURRED DURING AN EMERGENCY PROCEDURE, AND THE PATIENT PASSED AWAY DURING THE PROCEDURE. BASED ON THE INFORMATION PROVIDED BY NOMA (B)(6), THE PATIENT¿S HEALTH OUTCOME WAS NOT RELATED TO THE FUNCTIONAL FAILURE OF THE EQUIPMENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT TO CONDUCT A THOROUGH INVESTIGATION.

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

  MAUDE report 23849285 ↗
• MalfunctionAug 20, 2025Radiation Output Problem; Radiation Output Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY RELEASE WAS POSSIBLE. THE PATIENT WAS MOVED, AND THE PROCEDURE WAS COMPLETED ON AN ALTERNATE UNIT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849454 ↗
• InjuryAug 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF AN INCIDENT WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. IT WAS REPORTED THAT A PATIENT RECEIVED BURN ON SKIN FOLLOWING THE TRANSARTERIAL CHEMOEMBOLIZATION PROCEDURE. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 22803788 ↗
• MalfunctionMay 3, 2024Use of Device Problem; Radiation Overexposure; Use of Device Problem; Radiation Overexposure

  ON APRIL 22, 2024, SIEMENS BECAME AWARE OF AN INCREASED RADIATION DOSE DUE TO THE IMPROPER INSERTION OF THE GRID INTO THE ARTIS ICONO FLOOR UNIT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION ABOUT THIS EVENT; THE EVENT IS REPORTED IN DOUBT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 19238291 ↗
• MalfunctionApr 8, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  SIEMENS BECAME AWARE OF AN INCIDENT THAT OCCURRED ON THE ARTIS ICONO FLOOR SYSTEM. THE REPORTED EVENT OCCURRED DURING A PATIENT EXAMINATION. A CARBON ARMREST PROVIDED BY SIEMENS WAS PLACED BETWEEN THE TABLETOP AND THE MATTRESS. ACCORDING TO THE INFORMATION PROVIDED BY THE USER, THE PATIENT WAS NOT STRAPPED TO THE TABLETOP AND SEEMED TO BE AGITATED. AS A RESULT, THE PATIENT FELL OFF THE TABLE. WE HAVE NO INDICATIONS OF ANY SERIOUS ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19062678 ↗
• MalfunctionMar 6, 2024Electrical Power Problem; Electrical Power Problem

  SIEMENS BECAME AWARE OF A SYSTEM MALFUNCTION OF THE ARTIS ICONO FLOOR UNIT. THE SYSTEM FAILED TO SWITCH TO THE UPS (UNINTERRUPTABLE POWER SUPPLY). WE HAVE NO INDICATIONS OF ADVERSE EFFECTS ON THE HEALTH STATUS OF PATIENTS, USERS OR THIRD PARTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846327 ↗
• MalfunctionNov 16, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. THE USER REPORTED AN INTENDED SYSTEM MOVEMENT WITH THE PATIENT ON THE TABLE. THIS RESULTED IN PATIENT SLIDING OFF THE TABLE. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THERE ARE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. THE REPORTED EVENT OCCURRED IN THE UNITED KINGDOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807381 ↗
• MalfunctionOct 31, 2022Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. HIGH DOSE WAS REPORTED DURING AN INTERVENTIONAL PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT HAD NO VISIBLE SKIN REDNESS OR OTHER INJURIES; AND THE PATIENT'S CONDITION WAS BEING MONITORED. 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 15698337 ↗
• MalfunctionAug 31, 2022Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. THE USER REPORTED DURING AN INTERVENTIONAL PROCEDURE SIGNALS WERE DISPLAYED IN INADEQUATE QUALITY ON THE LARGE DISPLAY. THE PROCEDURE WAS CONTINUED AND FINISHED ON THE CONCERNED 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 SWITZERLAND..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327203 ↗
• MalfunctionNov 4, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO SYSTEM MOVEMENTS WERE 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 12750353 ↗
• MalfunctionSep 15, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO SYSTEM MOVEMENTS WERE 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 12473335 ↗
• MalfunctionJul 6, 2021Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. THE USER REPORTED THAT IMAGE QUALITY DEVICES AND THE CATHETER ARE NOT CLEARLY VISIBLE. 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 12120185 ↗
• MalfunctionApr 21, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT NO X-RAY OR 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 11699427 ↗
• MalfunctionJan 11, 2021Patient Data Problem; Patient Data Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHEN USING THE ARTIS ICONO FLOOR SYSTEM. THE REGISTERED NAME CHANGED DURING THE PATIENT EXAMINATION. THE PATIENT NAME CHANGED TO A DIFFERENT NAME RESULTING IN SOME IMAGES BEING FILED UNDER THE WRONG PATIENT. THE ISSUE WAS RECOGNIZED BY THE CUSTOMER AND WAS CORRECTED BEFORE THE IMAGES WERE SENT TO PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS). SIEMENS IS UNAWARE OF ANY ADVERSE EFFECT TO THE PATIENT'S HEALTH DUE TO THIS ISSUE. DETAILED CLARIFICATION OF THE EVENT ARE BEING INVESTIGATED, THEREFORE, THIS REPORT IS BEING SUBMITTED WITH AN ABUNDANCE OF CAUTION. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146131 ↗
• MalfunctionNov 30, 2020Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT DURING AN EMERGENCY PROCEDURE ON THE ARTIS ICONO FLOOR UNIT AN X-RAY IMAGE WAS PIXELATED. THE IMAGE WAS UNUSABLE FOR DIAGNOSIS, AND THE PROCEDURE HAD TO BE COMPLETED ON AN ALTERNATE SYSTEM. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10924598 ↗
• MalfunctionNov 25, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  SIEMENS SERVICE ORGANIZATION REPORTED A DOSE VALUE MISMATCH THAT OCCURRED ON THE ARTIS ICONO FLOOR UNIT. DOSE DISPLAYED ON LARGE DISPLAY WAS ABOUT 8 GY, AND DOSE IN THE CONTROL ROOM ON THE COCKPIT WAS REASONABLE, ABOUT 1.5 GY. DOSE VALUE CORRECTED BY ITSELF DURING THE CASE, HOWEVER, THE MISMATCH WAS NOTICED DURING THE CASE COMPARISON. NEXT PATIENT VALUES WERE CORRECT AND SAME ON LD AND COCKPIT SCREEN THROUGH THE CASE. AT THIS TIME, SIEMENS HAS NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905595 ↗
• MalfunctionAug 21, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO FLOOR 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 Known Impact Or Consequence To Patient

  MAUDE report 10435982 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190768, K220432, K230950, K241572, K254173. One submission often covers many models, so check the product and lot details in each record.

• Z-2642-2026 · May 20, 2026 · Open, Classified
  ARTIS icono ceiling. Model Number: 11328100.
• Z-2641-2026 · May 20, 2026 · Open, Classified
  ARTIS icono biplane. Model Number: 11327600.
• Z-1814-2026 · Mar 12, 2026 · Open, Classified
  ARTIS Pheno VE30A and VE40A, Model 10849000
• Z-2205-2026 · Mar 9, 2026 · Open, Classified
  ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
• Z-2529-2025 · Aug 12, 2025 · Open, Classified
  Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
• Z-2021-2025 · May 15, 2025 · Open, Classified
  interventional fluoroscopic x-ray system
• Z-2020-2025 · May 15, 2025 · Open, Classified
  interventional fluoroscopic x-ray system
• Z-2359-2023 · Jun 19, 2023 · Open, Classified
  ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
• Z-1245-2022 · Apr 11, 2022 · Open, Classified
  Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600